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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 K142700
Device Name InsufflatOR Needle
Applicant
Gynetech Pty. , Ltd.
Unit 7, 6-8 Macquarie Dr.
Thomastown,  AU 3095
Applicant Contact Kevin MacDonald
Correspondent
Macdonald Consulting
229 Marvilla Cir.
Pacifica,  CA  94044
Correspondent Contact Kevin MacDonald
Regulation Number884.1730
Classification Product Code
HIF  
Date Received09/22/2014
Decision Date 12/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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