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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 K931769
Device Name SNAP OSCILLATING SAW
Applicant
Surgiquip, Inc.
3106 Lafayette Ave.
Austin,  TX  78722
Applicant Contact MARY BIGGERS
Correspondent
Surgiquip, Inc.
3106 Lafayette Ave.
Austin,  TX  78722
Correspondent Contact MARY BIGGERS
Regulation Number878.4820
Classification Product Code
GFA  
Date Received04/09/1993
Decision Date 01/27/1994
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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