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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transducer, pressure, intrauterine
510(k) Number K973746
Device Name PRE-FILLED SYRINGE FOR KOALA IUP
Applicant
CLINICAL INNOVATIONS, INC.
6477 SOUTH COTTONWOOD ST.
MURRAY,  UT  84107
Applicant Contact DEAN WALLACE
Correspondent
CLINICAL INNOVATIONS, INC.
6477 SOUTH COTTONWOOD ST.
MURRAY,  UT  84107
Correspondent Contact DEAN WALLACE
Regulation Number884.2700
Classification Product Code
HFN  
Date Received10/01/1997
Decision Date 11/24/1997
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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