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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 K122180
Device Name HIGH FLOW INSUFFLANTION UNIT
Original Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 corporate parkway
po box 610
center valley,  PA  18034 -0610
Original Contact daphney germain-kolawole
Regulation Number884.1730
Classification Product Code
HIF  
Subsequent Product Codes
FCX   OSV  
Date Received07/23/2012
Decision Date 11/13/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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