510(k) K862852

MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR by Micro-Aire Surgical Instruments, Inc. — Product Code GFF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1986
Date Received
July 29, 1986
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