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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 K933094
FOIA Releasable 510(k) K933094
Device Name INSUFFLATOR TUBING KIT W/FILTER
Applicant
INMAN MEDICAL CORP.
6316 AIRPORT FREEWAY
FORT WORTH,  TX  76117
Applicant Contact PAM LIBERTO
Correspondent
INMAN MEDICAL CORP.
6316 AIRPORT FREEWAY
FORT WORTH,  TX  76117
Correspondent Contact PAM LIBERTO
Regulation Number884.1730
Classification Product Code
HIF  
Date Received06/24/1993
Decision Date 04/18/1994
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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