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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 Pkwy.
Center Valley,  PA  18034
Applicant Contact STACY ABBATIELLO KLUESNER
Correspondent
Olympus Medical Systems Corporation
3500 Corporate Pkwy.
Center Valley,  PA  18034
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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