CODMAN SKULL CLAMP

Holder, Head, Neurosurgical (skull Clamp)

Codman & Shurtleff, Inc.

The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Skull Clamp.

Pre-market Notification Details

Device IDK912011
510k NumberK912011
Device Name:CODMAN SKULL CLAMP
ClassificationHolder, Head, Neurosurgical (skull Clamp)
Applicant Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph,  MA  02368 -1794
ContactThomas J Courage
CorrespondentThomas J Courage
Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph,  MA  02368 -1794
Product CodeHBL  
CFR Regulation Number882.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-06
Decision Date1991-07-31

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