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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
510(k) Number K875137
Device Name LAPAROFLATOR 3000, STANDARD AND ELECTRONIC
Applicant
F.M. Wiest USA, Inc.
1301 N. Kings Hwy.
Cherry Hill,  NJ  08034
Applicant Contact WAYNE W DISANZA
Correspondent
F.M. Wiest USA, Inc.
1301 N. Kings Hwy.
Cherry Hill,  NJ  08034
Correspondent Contact WAYNE W DISANZA
Regulation Number884.1300
Classification Product Code
HES  
Date Received12/15/1987
Decision Date 03/02/1988
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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