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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 K132931
Device Name APOLLO SYSTEM
Applicant
Penumbra, Inc.
1351 Harbor Bay Pkwy.
Alameda,  CA  94502
Applicant Contact SETH SCHULMAN
Correspondent
Penumbra, Inc.
1351 Harbor Bay Pkwy.
Alameda,  CA  94502
Correspondent Contact SETH SCHULMAN
Regulation Number882.1480
Classification Product Code
GWG  
Date Received09/18/2013
Decision Date 01/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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