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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Neurological
510(k) Number K043128
Device Name OLYMPUS ENDOARM
Applicant
OLYMPUS CORPORATION
TWO CORPORATE CENTER DRIVE
MELVILLE,  NY  11747 -3157
Applicant Contact TINA STEFFANIE-OAK
Correspondent
ENTELA, INC.
3033 MADISON AVENUE, SE
GRAND RAPIDS,  MI  49548
Correspondent Contact NEIL E DEVINE
Regulation Number882.1480
Classification Product Code
GWG  
Date Received11/12/2004
Decision Date 12/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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