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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 S. St.
Oyster Bay,  NY  11771
Applicant Contact LAUREN R ANDERSEN
Correspondent
H.W. Andersen Products, Inc.
221 S. 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
Predetermined Change
Control Plan Authorized		 No
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