The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Biatain Agfoam Dressings-non-adhesiv: 5x7cm, 10x10cm, 10x20cm,15x15cm & 20x20cm.
| Device ID | K100218 |
| 510k Number | K100218 |
| Device Name: | BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM |
| 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 | 2010-01-26 |
| Decision Date | 2010-02-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05708932100854 | K100218 | 000 |
| 05708932100823 | K100218 | 000 |
| 05708932100793 | K100218 | 000 |
| 05708932442121 | K100218 | 000 |
| 05708932369732 | K100218 | 000 |
| 05708932442107 | K100218 | 000 |