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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Balloon Inflation
510(k) Number K902695
Device Name DISPOSABLE INFLATION GAUGE
Applicant
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 227
Spencer,  IN  47460
Applicant Contact MICHELLE YOUNG
Correspondent
Cook Urological, Inc.
1100 W. Morgan St.
P.O. Box 227
Spencer,  IN  47460
Correspondent Contact MICHELLE YOUNG
Regulation Number870.1650
Classification Product Code
MAV  
Date Received06/19/1990
Decision Date 12/03/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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