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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K935592
Device Name SURGICAL ACCESSORIES COCR CABLE SYSTEM
Applicant
Surgical Accessories, Inc.
3165 Mckelvey Rd.
Suite 240a
St. Louis,  MO  63044
Applicant Contact STEPHEN E WHITE
Correspondent
Surgical Accessories, Inc.
3165 Mckelvey Rd.
Suite 240a
St. Louis,  MO  63044
Correspondent Contact STEPHEN E WHITE
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received11/19/1993
Decision Date 01/26/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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