510(k) K070596 ยท CCT Applicator (Laryngo-Tracheal), Topical Anesthesia
TOPICAL APPLICATOR
| Applicant | Sharn, Inc., Bonita Springs FL, US |
| Decision | Substantially Equivalent, Jun 21, 2007 |
| Received | Mar 2, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070596
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2009 | Sharn, Inc. Pediatric Laryngo-Tracheal Atomizer Device without syringe, LATEX FREE For Single patient Use Only Packaged Clean -Non-Sterile-, MADE IN CANADA.
REF: LTAD-PL7-25, Lot 121508, packed 25 per packag Terminated |
CCT | None listed |
| Nov 16, 2009 | Sharn, Inc. Nasal Mucosal Atomizer Device with syringe, LATEX FREE For Single Patient Use Only Packaged Clean -Non-Sterile- MADE IN CANADA.
REF: LTAD-N1-25, Lot 121608, packed 25 per package.
REF: LTAD-N1-100, Terminated |
CCT | None listed |
| Nov 16, 2009 | Sharn, Inc. Nasal Mucosal Atomizer Device without syringe, LATEX FREE For Single Patient Use Only Packaged Clean -Non-Sterile- MADE IN CANADA.
REF: LTAD-N3-25, Lot 121608, packed 25 per package.
REF: LTAD-N3-1 Terminated |
CCT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.