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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name insufflator, hysteroscopic
510(k) Number K900908
Device Name CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200
Applicant
ZIMMER, INC.
200 W. OHIO AVE.
P.O. BOX 10
DOVER,  OH  44622
Applicant Contact PAULA OSORIO
Correspondent
ZIMMER, INC.
200 W. OHIO AVE.
P.O. BOX 10
DOVER,  OH  44622
Correspondent Contact PAULA OSORIO
Regulation Number884.1700
Classification Product Code
HIG  
Date Received02/27/1990
Decision Date 05/21/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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