FDA 510(k) Application Details - K973183

Device Classification Name Accessories, Catheter

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510(K) Number K973183
Device Name Accessories, Catheter
Applicant R & D MEDICAL PRODUCTS, INC.
18 BLESSING
IRVINE, CA 92612 US
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Regulation Number 878.4200

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Classification Product Code KGZ
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Date Received 08/25/1997
Decision Date 01/23/1998
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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