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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 K924481
Device Name INSUFFLATION TUBING
Applicant
APPLIED MEDICAL RESOURCES
26051 MERIT CIRCLE
BUILDING 104
LAGUNA HILLS,  CA  92653
Applicant Contact JO STEGWELL
Correspondent
APPLIED MEDICAL RESOURCES
26051 MERIT CIRCLE
BUILDING 104
LAGUNA HILLS,  CA  92653
Correspondent Contact JO STEGWELL
Regulation Number884.1730
Classification Product Code
HIF  
Date Received09/03/1992
Decision Date 03/22/1994
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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