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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 K921871
Device Name HYSTEROMAT(TM) 3700
Applicant
F.M. Wiest USA, Inc.
690 Kinderkamack Rd., 1st Floor
P.O. Box 637
Oradell,  NJ  07649
Applicant Contact GEORGE BATCHELOR
Correspondent
F.M. Wiest USA, Inc.
690 Kinderkamack Rd., 1st Floor
P.O. Box 637
Oradell,  NJ  07649
Correspondent Contact GEORGE BATCHELOR
Regulation Number884.1700
Classification Product Code
HIG  
Date Received04/20/1992
Decision Date 12/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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