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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K901722
Device Name CHEMOSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM
Applicant
Device Labs, Inc.
3 Industrial Park Rd.
Medway,  MA  02053
Applicant Contact ELTON M TUCKER
Correspondent
Device Labs, Inc.
3 Industrial Park Rd.
Medway,  MA  02053
Correspondent Contact ELTON M TUCKER
Regulation Number880.5965
Classification Product Code
LJT  
Date Received04/16/1990
Decision Date 07/03/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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