The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Biatain Foam Dressing.
| Device ID | K983163 |
| 510k Number | K983163 |
| Device Name: | BIATAIN FOAM DRESSING |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | COLOPLAST CORP. 1955 WEST OAK CIR. Marietta, GA 30062 -2249 |
| Contact | M. Sydney Lilly |
| Correspondent | M. Sydney Lilly COLOPLAST CORP. 1955 WEST OAK CIR. Marietta, GA 30062 -2249 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-10 |
| Decision Date | 1998-12-16 |
| Summary: | summary |