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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name aspirator, endocervical
510(k) Number K954903
Device Name PEDI VAGINAL ASPIRATOR
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 Number884.1050
Classification Product Code
HFC  
Date Received10/25/1995
Decision Date 04/29/1996
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
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