510(k) K191536
K191536 is an FDA 510(k) premarket notification submitted by Coloplast A/S for the device "Biatain Silicone Ag". The FDA issued a decision of Substantially Equivalent on Feb 21, 2020. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Coloplast A/S has 139 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 21, 2020
- Date Received
- Jun 10, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)