FDA 510(k) Application Details - K011727

Device Classification Name Trocar

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510(K) Number K011727
Device Name Trocar
Applicant THOMAS MEDICAL PRODUCTS, INC.
65 GREAT VALLEY PKWY.
MALVERN, PA 19355 US
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Contact TIM STOUDT
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Regulation Number 870.1390

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Classification Product Code DRC
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Date Received 06/04/2001
Decision Date 05/02/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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