510(k) K883338 ยท KYZ Syringe, Irrigating (Non Dental)
SURGICAL SEALANT APPLICATOR
| Applicant | Micromedics, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Aug 23, 1988 |
| Received | Aug 9, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883338
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2012 | Haemacure Corporation HemaSyst, Dual Cannula Tip with Adapter 16 ga. x 4" (10.2 cm). Product is labeled in part:"***Pouch label***HAEMACURE***HemaSyst***tm***Contents: One ***DUAL CANNULA TIP***WITH ADAPTER***16 ga. x 4" Terminated |
KYZ | None listed |
| Nov 18, 2010 | Micromedics, Inc. AMS600-B, AMS700-B, SA-0105, SA-3675, SA-3678
Arteriocyte Medical systems, Magellan, Cannula Tip, Catalog Number
AMS600-B,Sterilized by Ethylene Oxide, Rx Only, Manufacturer Micromedics Inc., St. Pau Terminated |
KYZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.