510(k) K982465 ยท OCT Anti Fog Solution And Accessories, Endoscopy
DEROYAL INDUSTRIES, INC. DEFOGGER
| Applicant | Deroyal Industries, Inc., Powell TN, US |
| Decision | Substantially Equivalent, Aug 11, 1998 |
| Received | Jul 15, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982465
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2019 | Medline Industries, Inc. Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, Open, Classified |
OCT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.