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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Nephrostomy, General & Plastic Surgery
510(k) Number K021632
Device Name GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C
Applicant
URESIL, L.P.
5418 WEST TOUHY AVE.
SKOKIE,  IL  60077
Applicant Contact CHARLES P GILL
Correspondent
URESIL, L.P.
5418 WEST TOUHY AVE.
SKOKIE,  IL  60077
Correspondent Contact CHARLES P GILL
Regulation Number878.4200
Classification Product Code
GBO  
Date Received05/17/2002
Decision Date 06/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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