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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accessories, catheter
510(k) Number K973183
Device Name WOUND DRAINAGE HOLDER
Applicant
R & D MEDICAL PRODUCTS, INC.
18 BLESSING
IRVINE,  CA  92612
Correspondent
R & D MEDICAL PRODUCTS, INC.
18 BLESSING
IRVINE,  CA  92612
Regulation Number878.4200
Classification Product Code
KGZ  
Date Received08/25/1997
Decision Date 01/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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