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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pump, portable, aspiration (manual or powered)
510(k) Number K944818
Device Name COOK ASPIRATION/IRRIGATION UNIT
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Applicant Contact TAMMY BACON
Correspondent
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Correspondent Contact TAMMY BACON
Regulation Number878.4780
Classification Product Code
BTA  
Date Received09/29/1994
Decision Date 11/08/1994
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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