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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 K915694
Device Name MEDITRON ELECTRONIC LAPAROSCOPIC INSUFFLATOR
Applicant
Medical Devices, Inc.
83 Hobart St.
Hackensack,  NJ  07601
Applicant Contact SAMUEL DICKSTEIN
Correspondent
Medical Devices, Inc.
83 Hobart St.
Hackensack,  NJ  07601
Correspondent Contact SAMUEL DICKSTEIN
Regulation Number884.1730
Classification Product Code
HIF  
Date Received12/23/1991
Decision Date 06/18/1992
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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