510(k) K872491

1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS by Micro-Aire Surgical Instruments, Inc. — Product Code GEG

K872491 is an FDA 510(k) premarket notification submitted by Micro-Aire Surgical Instruments, Inc. for the device "1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS". The FDA issued a decision of Substantially Equivalent on July 16, 1987. The device falls under product code GEG (Elevator, Surgical, General & Plastic Surgery), 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
July 16, 1987
Date Received
June 23, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elevator, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type