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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bulb, Inflation, For Endoscope
510(k) Number K900016
Device Name TRANS/R - FP(3)
Applicant
CIVCO Medical Instruments Co., Inc.
418 B Ave.
Kalona,  IA  52247
Applicant Contact J WEDEL
Correspondent
CIVCO Medical Instruments Co., Inc.
418 B Ave.
Kalona,  IA  52247
Correspondent Contact J WEDEL
Regulation Number876.1500
Classification Product Code
FCY  
Date Received01/02/1990
Decision Date 06/11/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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