MINOP Disposable Introducer 26F

Endoscope, Neurological

AESCULAP, INC.

The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Minop Disposable Introducer 26f.

Pre-market Notification Details

Device IDK142315
510k NumberK142315
Device Name:MINOP Disposable Introducer 26F
ClassificationEndoscope, Neurological
Applicant AESCULAP, INC. 3773 Corporate Parkway Center Valley,  PA  18034
ContactKathy Racosky
CorrespondentCorina Duffy
MEDCOMP (MEDICAL COMPONENTS, INC.) 1499 DELP DR. Harleysville,  PA  19438
Product CodeGWG  
CFR Regulation Number882.1480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-19
Decision Date2014-11-14

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