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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trephine, Manual, Ophthalmic
510(k) Number K864520
Device Name BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON
Applicant
Precision Instruments, Inc.
6437 Carriage Hill Dr.
Grand Blanc,  MI  48439
Applicant Contact MILFORD BARRON
Correspondent
Precision Instruments, Inc.
6437 Carriage Hill Dr.
Grand Blanc,  MI  48439
Correspondent Contact MILFORD BARRON
Regulation Number886.4350
Classification Product Code
HRH  
Date Received11/17/1986
Decision Date 01/20/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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