The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Coverage Hbv.
| Device ID | K964749 |
| 510k Number | K964749 |
| Device Name: | COVERAGE HBV |
| Classification | Disinfectant, Medical Devices |
| Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 5035 MANCHESTER AVE. St. Louis, MO 63110 |
| Contact | Michael G Sarli |
| Correspondent | Michael G Sarli CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 5035 MANCHESTER AVE. St. Louis, MO 63110 |
| Product Code | LRJ |
| CFR Regulation Number | 880.6890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-26 |
| Decision Date | 1996-12-13 |
| Summary: | summary |