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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 K911844
Device Name HYSTEROFLATOR 1500
Applicant
F.M. Wiest USA, Inc.
P.O. Box 637
Oradel,  NJ  07649
Applicant Contact GEORGE R BATCHELOR
Correspondent
F.M. Wiest USA, Inc.
P.O. Box 637
Oradel,  NJ  07649
Correspondent Contact GEORGE R BATCHELOR
Regulation Number884.1700
Classification Product Code
HIG  
Date Received04/25/1991
Decision Date 11/21/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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