The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Biatain Silicone Ag Foam Dressing - Adhesive: 3x3 Inches, 4x4 Inches, & 5x5 Inches.
| Device ID | K120828 |
| 510k Number | K120828 |
| Device Name: | BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES |
| Classification | Dressing, Wound, Drug |
| Applicant | COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis, MN 55411 |
| Contact | Rebeka Stoltman |
| Correspondent | Rebeka Stoltman COLOPLAST A/S 1601 WEST RIVER ROAD NORTH Minneapolis, MN 55411 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2012-03-19 |
| Decision Date | 2012-04-05 |
| Summary: | summary |