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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
510(k) Number K935322
Device Name SNAP BONE REAMER
Applicant
Surgiquip, Inc.
1799 E. 71st St.
Tulsa,  OK  74136
Applicant Contact MARY BIGGERS
Correspondent
Surgiquip, Inc.
1799 E. 71st St.
Tulsa,  OK  74136
Correspondent Contact MARY BIGGERS
Regulation Number878.4820
Classification Product Code
HWE  
Date Received11/04/1993
Decision Date 01/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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