510(k) K820281
K820281 is an FDA 510(k) premarket notification submitted by Micro-Aire Surgical Instruments, Inc. for the device "MICRO-AIRE REPLACEMENT DRILL BURS". The FDA issued a decision of Substantially Equivalent on February 23, 1982. The device falls under product code GFF (Bur, Surgical, General & Plastic Surgery), 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 23, 1982
- Date Received
- February 2, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bur, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type