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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 K922197
Device Name INSUFFLATOR TUBING KIT
Applicant
O.R. CONCEPTS, INC.
200 N. OAK ST.
ROANOKE,  TX  76262
Applicant Contact JOHN MAYALL
Correspondent
O.R. CONCEPTS, INC.
200 N. OAK ST.
ROANOKE,  TX  76262
Correspondent Contact JOHN MAYALL
Regulation Number884.1700
Classification Product Code
HIG  
Subsequent Product Code
HIF  
Date Received05/11/1992
Decision Date 09/24/1993
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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