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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Snare, Surgical
510(k) Number K950776
Device Name BIPOLAR SNARE
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 271
SPENCER,  IN  47460
Applicant Contact DARCY JOB
Correspondent
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 271
SPENCER,  IN  47460
Correspondent Contact DARCY JOB
Regulation Number878.4800
Classification Product Code
GAE  
Date Received02/21/1995
Decision Date 04/18/1995
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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