510(k) K053636 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE)
| Applicant | Mani, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Mar 14, 2006 |
| Received | Dec 29, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053636
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Mani, Inc. - Kiyohara Facility MANI Needle and Suture Pack, 8-0 PGA Absorbable, Model 2090, 30 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, In Terminated |
GAM | None listed |
| Jan 11, 2012 | Mani, Inc. - Kiyohara Facility MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2091, 30 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, In Terminated |
GAM | None listed |
| Jan 11, 2012 | Mani, Inc. - Kiyohara Facility MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2092, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, In Terminated |
GAM | None listed |
| Jan 11, 2012 | Mani, Inc. - Kiyohara Facility MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2490, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, In Terminated |
GAM | None listed |
| Jan 11, 2012 | Mani, Inc. - Kiyohara Facility MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2890, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, In Terminated |
GAM | None listed |
| Jan 11, 2012 | Mani, Inc. - Kiyohara Facility MANI Needle and Suture Pack, 5-0 PGA Absorbable, Model 3391, 45 cm suture and needle, packaged in individual aluminum pack, within tyvek packaging, 12 packages per box, and labeled in part ***Mani, In Terminated |
GAM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.