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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Needle, Gastroenterologic
510(k) Number K920706
Device Name MAGNETIC POINT GUARD FOR SURGICAL NEEDLES
Applicant
Retrax
800 W. Wausau Cir.
Wausau,  WI  54401
Applicant Contact DONALD KRANENDOBK
Correspondent
Retrax
800 W. Wausau Cir.
Wausau,  WI  54401
Correspondent Contact DONALD KRANENDOBK
Regulation Number876.4730
Classification Product Code
FHQ  
Date Received02/18/1992
Decision Date 05/26/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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