510(k) K850819
K850819 is an FDA 510(k) premarket notification submitted by Geistlich-Pharma for the device "GELIPERM ABSORBIND GRANULATED GEL". The FDA issued a decision of Substantially Equivalent on May 7, 1985. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Geistlich-Pharma has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 7, 1985
- Date Received
- February 28, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type