510(k) K874503
K874503 is an FDA 510(k) premarket notification submitted by Micro-Aire Surgical Instruments, Inc. for the device "MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER". The FDA issued a decision of Substantially Equivalent on December 2, 1987. The device falls under product code HWM (Osteotome), a Class I device regulated under 21 CFR 878.4800. Micro-Aire Surgical Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 1987
- Date Received
- November 2, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Osteotome
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type