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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Circumcision
510(k) Number K063429
Device Name GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200
Applicant
Generic Medical Device, Inc.
3906 Roseland St.
Houston,  TX  77006
Applicant Contact MONICA MONTANEZ
Correspondent
Generic Medical Device, Inc.
3906 Roseland St.
Houston,  TX  77006
Correspondent Contact MONICA MONTANEZ
Regulation Number884.4530
Classification Product Code
HFX  
Date Received11/13/2006
Decision Date 01/17/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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