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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 K033403
Device Name T.S. MEDICAL CIRCUMCISION CLAMP
Applicant
T.S. MEDICAL
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Applicant Contact CAROLANN KOTULA
Correspondent
T.S. MEDICAL
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Correspondent Contact CAROLANN KOTULA
Regulation Number884.4530
Classification Product Code
HFX  
Date Received10/24/2003
Decision Date 01/22/2004
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
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