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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K852680
Device Name TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG
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 Number884.1720
Classification Product Code
HET  
Date Received06/25/1985
Decision Date 12/23/1985
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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