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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
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