FDA 510(k) Application Details - K960426

Device Classification Name Catheter, Peritoneal

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510(K) Number K960426
Device Name Catheter, Peritoneal
Applicant MEDICAL COMPONENTS, INC.
1499 DELP DR.
HARLEYSVILLE, PA 19438 US
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Contact MICHELLE DEMERS
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Regulation Number 878.4200

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Classification Product Code GBW
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Date Received 01/29/1996
Decision Date 03/21/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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