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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 K061135
Device Name MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019
Applicant
AESCULAP
1499 DELP DRIVE
HARLYSVILLE,  PA  19438
Applicant Contact LISA WEIKERT
Correspondent
AESCULAP
1499 DELP DRIVE
HARLYSVILLE,  PA  19438
Correspondent Contact LISA WEIKERT
Regulation Number882.1480
Classification Product Code
GWG  
Date Received04/24/2006
Decision Date 07/11/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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