The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Biatain Silicone Ag.
| Device ID | K191536 |
| 510k Number | K191536 |
| Device Name: | Biatain Silicone Ag |
| Classification | Dressing, Wound, Drug |
| Applicant | Coloplast A/S Holtedam 1 Humlebaek, DK 3050 |
| Contact | Kimberly Tokach |
| Correspondent | Lykke Forchhammer Coloplast A/S Holtedam 1 3050 Humlebaek DK |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-06-10 |
| Decision Date | 2020-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05708932730594 | K191536 | 000 |
| 05701780210355 | K191536 | 000 |
| 05701780210416 | K191536 | 000 |
| 05701780210379 | K191536 | 000 |
| 05701780210393 | K191536 | 000 |
| 05708932730259 | K191536 | 000 |
| 05708932730501 | K191536 | 000 |
| 05708932730532 | K191536 | 000 |
| 05708932730570 | K191536 | 000 |
| 05701780210348 | K191536 | 000 |