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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 K043533
Device Name SURGICAL DESIGN CIRCUMCISION CLAMP
Applicant
Surgical Design, Inc.
7351-D Lockport Pl
Lorton,  VA  22079
Applicant Contact MOHAMMAD BASHIR
Correspondent
Surgical Design, Inc.
7351-D Lockport Pl
Lorton,  VA  22079
Correspondent Contact Mohammad Bashir
Regulation Number884.4530
Classification Product Code
HFX  
Date Received12/22/2004
Decision Date 04/01/2005
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
Recalls CDRH Recalls
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