510(k) K182838
K182838 is an FDA 510(k) premarket notification submitted by Geistlich Pharma AG for the device "Geistlich Derma-Gide". The FDA issued a decision of Substantially Equivalent on Nov 8, 2018. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Geistlich Pharma AG has 26 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 8, 2018
- Date Received
- Oct 9, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Dressing With Animal-Derived Material(S)
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)