510(k) K870157
K870157 is an FDA 510(k) premarket notification submitted by Micro-Aire Surgical Instruments, Inc. for the device "OSCILLATING SAW/ RECIPROCATING SAW/ DRILL-REAMER". The FDA issued a decision of Substantially Equivalent on February 24, 1987. The device falls under product code KFK (Saw, Pneumatically Powered), a Class I device regulated under 21 CFR 878.4820. Micro-Aire Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 1987
- Date Received
- January 13, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Saw, Pneumatically Powered
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type