510(k) K881020 ยท KYZ Syringe, Irrigating (Non Dental)
SURGICAL SEALANT DISPENSER (SSD)
| Applicant | Micromedics, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Mar 25, 1988 |
| Received | Mar 10, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881020
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2010 | Micromedics, Inc. ATM100, LB-AP-M0001
Fibrijet, Catalog Number ATM100, Autoloous Thrombin Mixer (Blending Connector), Micromedics, Sterilized by Ethylene Oxide, Rx Only, MicromedicsInc., St Paul, MN 55121-1385.
Distr Terminated |
KYZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.