The following data is part of a premarket notification filed by James River Corp. with the FDA for Cotolin Drain Sponge And Dressing Sponge.
| Device ID | K894505 |
| 510k Number | K894505 |
| Device Name: | COTOLIN DRAIN SPONGE AND DRESSING SPONGE |
| Classification | Gauze/sponge, Internal |
| Applicant | JAMES RIVER CORP. 1915 MARATHON AVE. Neenah, WI 54956 |
| Contact | Richard L Davis |
| Correspondent | Richard L Davis JAMES RIVER CORP. 1915 MARATHON AVE. Neenah, WI 54956 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-19 |
| Decision Date | 1989-09-15 |