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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 K110294
Device Name HIGH FLOW INSUFFLATION UNIT UHI-4
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
CENTER VALLEY,  PA  18034 -0610
Applicant Contact STACY ABBATIELLO KLUESNER
Correspondent
OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
CENTER VALLEY,  PA  18034 -0610
Correspondent Contact STACY ABBATIELLO KLUESNER
Regulation Number884.1730
Classification Product Code
HIF  
Subsequent Product Code
OSV  
Date Received02/01/2011
Decision Date 11/18/2011
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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