510(k) K802646
K802646 is an FDA 510(k) premarket notification submitted by B & F Medical Products, Inc. for the device "HAND PERCUSSOR CUP #65210". The FDA issued a decision of Substantially Equivalent on November 12, 1980. The device falls under product code BYI (Percussor, Powered-Electric), a Class II device regulated under 21 CFR 868.5665. B & F Medical Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 1980
- Date Received
- October 24, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Percussor, Powered-Electric
- Device Class
- Class II
- Regulation Number
- 868.5665
- Review Panel
- AN
- Submission Type