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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 K941239
Device Name AESCULAP NEUROENDOSCOPE
Applicant
AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Applicant Contact VICTORIA MACKINNON
Correspondent
AESCULAP, INC.
1000 GATEWAY BLVD.
SOUTH SAN FRANCISCO,  CA  94080
Correspondent Contact VICTORIA MACKINNON
Regulation Number882.1480
Classification Product Code
GWG  
Date Received03/15/1994
Decision Date 07/11/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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