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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 K040052
Device Name FINE SURGICAL CIRCUMCISION CLAMP
Applicant
Fine Surgical Instrument Corp.
55 Northern Blvd.
Great Neck,  NY  11021
Applicant Contact CAROLANN KOTULA
Correspondent
Fine Surgical Instrument Corp.
55 Northern Blvd.
Great Neck,  NY  11021
Correspondent Contact CAROLANN KOTULA
Regulation Number884.4530
Classification Product Code
HFX  
Date Received01/12/2004
Decision Date 04/09/2004
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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