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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K963359
Device Name INSUFFLATION NEEDLE
Applicant
APPLIED MEDICAL RESOURCES
26051 MERIT CIRCLE
BUILDING 104
LAGUNA HILLS,  CA  92653
Applicant Contact HOWARD V ROWE
Correspondent
APPLIED MEDICAL RESOURCES
26051 MERIT CIRCLE
BUILDING 104
LAGUNA HILLS,  CA  92653
Correspondent Contact HOWARD V ROWE
Regulation Number884.1720
Classification Product Code
HET  
Date Received08/26/1996
Decision Date 09/24/1996
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
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