510(k) K033815
K033815 is an FDA 510(k) premarket notification submitted by Geistlich-Pharma for the device "BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN". The FDA issued a decision of Substantially Equivalent on January 15, 2004. The device falls under product code NPM (Bone Grafting Material, Animal Source), a Class II device regulated under 21 CFR 872.3930. Geistlich-Pharma has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 15, 2004
- Date Received
- December 9, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bone Grafting Material, Animal Source
- Device Class
- Class II
- Regulation Number
- 872.3930
- Review Panel
- DE
- Submission Type
A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.