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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K912044
Device Name MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR
Applicant
Multigon Industries, Inc.
P.O. Box 2485
Mt. Vernon,  NY  10551
Applicant Contact WILLIAM STERN
Correspondent
Multigon Industries, Inc.
P.O. Box 2485
Mt. Vernon,  NY  10551
Correspondent Contact WILLIAM STERN
Regulation Number884.1730
Classification Product Code
HIF  
Date Received05/08/1991
Decision Date 06/24/1991
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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