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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name accessory, assisted reproduction
510(k) Number K992070
Device Name COOK ULTRA QUIET VACUUM PUMP & REGULATOR
Applicant
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Applicant Contact BRENDA DAVIS
Correspondent
COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER,  IN  47460
Correspondent Contact BRENDA DAVIS
Regulation Number884.6120
Classification Product Code
MQG  
Date Received06/18/1999
Decision Date 10/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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