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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
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
PO BOX 610
CENTER VALLEY,  PA  18034 -0610
Applicant Contact DAPHNEY GERMAIN-KOLAWOLE
Correspondent
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
PO BOX 610
CENTER VALLEY,  PA  18034 -0610
Correspondent 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 Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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