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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, ventricular, general & plastic surgery
510(k) Number K872457
Device Name AN3500 WORTH DRAIN
Applicant
H.W. ANDERSEN PRODUCTS, INC.
221 SOUTH ST.
OYSTER BAY,  NY  11771
Applicant Contact LAUREN R ANDERSEN
Correspondent
H.W. ANDERSEN PRODUCTS, INC.
221 SOUTH ST.
OYSTER BAY,  NY  11771
Correspondent Contact LAUREN R ANDERSEN
Regulation Number878.4200
Classification Product Code
GBS  
Date Received06/23/1987
Decision Date 07/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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