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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cholangiography
510(k) Number K901520
Device Name WURTZ CHOLEY CLIP (TM)
Applicant
Cd Medical, Inc.
1709 Queensbury Cir.
Hoffman Estates,  IL  60195
Applicant Contact PATRICIA K O'GORMAN
Correspondent
Cd Medical, Inc.
1709 Queensbury Cir.
Hoffman Estates,  IL  60195
Correspondent Contact PATRICIA K O'GORMAN
Regulation Number878.4200
Classification Product Code
GBZ  
Date Received04/02/1990
Decision Date 06/26/1990
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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