FDA 510(k) Application Details - K033403

Device Classification Name Clamp, Circumcision

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510(K) Number K033403
Device Name Clamp, Circumcision
Applicant T.S. MEDICAL
55 Northern Blvd.
Suite 200
Great Neck, NY 11021 US
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Contact CAROLANN KOTULA
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Regulation Number 884.4530

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Classification Product Code HFX
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Date Received 10/24/2003
Decision Date 01/22/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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