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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 K905495
Device Name HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR
Applicant
FRIGITRONICS, INC.
1963 ROCK ST.
SUITE 17
MOUNTAIN VIEW,  CA  94043
Applicant Contact CHARLES L ROSE
Correspondent
FRIGITRONICS, INC.
1963 ROCK ST.
SUITE 17
MOUNTAIN VIEW,  CA  94043
Correspondent Contact CHARLES L ROSE
Regulation Number884.1700
Classification Product Code
HIG  
Date Received12/07/1990
Decision Date 04/29/1991
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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