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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 K925558
Device Name INFILTUBE
Applicant
Medsurg Industries, Inc.
251 Exchange Pl.
Herndon,  VA  20170
Applicant Contact THOMAS BONNER
Correspondent
Medsurg Industries, Inc.
251 Exchange Pl.
Herndon,  VA  20170
Correspondent Contact THOMAS BONNER
Regulation Number884.1730
Classification Product Code
HIF  
Date Received11/03/1992
Decision Date 03/04/1994
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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