510(k) K870329
K870329 is an FDA 510(k) premarket notification submitted by Biodynamic Technologies, Inc. for the device "ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202". The FDA issued a decision of Substantially Equivalent on February 13, 1987. The device falls under product code HTR (Rasp), a Class I device regulated under 21 CFR 878.4800. Biodynamic Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1987
- Date Received
- January 28, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rasp
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type