510(k) K822108
K822108 is an FDA 510(k) premarket notification submitted by Bio-Blitz, Inc. for the device "CEMENT-PICK". The FDA issued a decision of Substantially Equivalent on August 11, 1982. The device falls under product code GAF (Spatula, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Bio-Blitz, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 1982
- Date Received
- July 19, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spatula, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type