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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 PLACE
HERNDON,  VA  20170 -4822
Applicant Contact THOMAS BONNER
Correspondent
MEDSURG INDUSTRIES, INC.
251 EXCHANGE PLACE
HERNDON,  VA  20170 -4822
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
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