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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blade, Saw, General & Plastic Surgery, Surgical
510(k) Number K912761
Device Name SURGICAL SAW BLADES
Applicant
Blairden Precision Instruments, Inc.
P.O. Box 16598
Fort Worth,  TX  76162
Applicant Contact RICHARD HAMER
Correspondent
Blairden Precision Instruments, Inc.
P.O. Box 16598
Fort Worth,  TX  76162
Correspondent Contact RICHARD HAMER
Regulation Number878.4820
Classification Product Code
GFA  
Date Received06/24/1991
Decision Date 07/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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