CODMAN QUICK SHUNT KIT, CAT. #82-6570

Endoscope, Neurological

Codman & Shurtleff, Inc.

The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Quick Shunt Kit, Cat. #82-6570.

Pre-market Notification Details

Device IDK934196
510k NumberK934196
Device Name:CODMAN QUICK SHUNT KIT, CAT. #82-6570
ClassificationEndoscope, Neurological
Applicant Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph,  MA  02368 -1794
ContactAmy Walters
CorrespondentAmy Walters
Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph,  MA  02368 -1794
Product CodeGWG  
CFR Regulation Number882.1480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-26
Decision Date1994-04-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886704044635 K934196 000
10886704044321 K934196 000
10886704044314 K934196 000
10886704044307 K934196 000

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