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FDA 510(k) Application Details - K973183
Device Classification Name
Accessories, Catheter
More FDA Info for this Device
510(K) Number
K973183
Device Name
Accessories, Catheter
Applicant
R & D MEDICAL PRODUCTS, INC.
18 BLESSING
IRVINE, CA 92612 US
Other 510(k) Applications for this Company
Regulation Number
878.4200
More FDA Info for this Regulation Number
Classification Product Code
KGZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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