510(k) K971692
K971692 is an FDA 510(k) premarket notification submitted by Osteomed Corp. for the device "OSTEOPOWER SYSTEM AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on June 27, 1997. The device falls under product code KMW (Handpiece, Rotary Bone Cutting), a Class II device regulated under 21 CFR 872.4120. Osteomed Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 1997
- Date Received
- May 7, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Rotary Bone Cutting
- Device Class
- Class II
- Regulation Number
- 872.4120
- Review Panel
- DE
- Submission Type