SPOTLIGHT ACCESS SYSTEM

Retractor, Self-retaining, For Neurosurgery

JOHNSON & JOHNSON

The following data is part of a premarket notification filed by Johnson & Johnson with the FDA for Spotlight Access System.

Pre-market Notification Details

Device IDK112913
510k NumberK112913
Device Name:SPOTLIGHT ACCESS SYSTEM
ClassificationRetractor, Self-retaining, For Neurosurgery
Applicant JOHNSON & JOHNSON 325 Paramount Drive Raynham,  MA  02767
ContactLaura Bleyendaal
CorrespondentLaura Bleyendaal
JOHNSON & JOHNSON 325 Paramount Drive Raynham,  MA  02767
Product CodeGZT  
CFR Regulation Number882.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-10-03
Decision Date2011-12-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10705034358376 K112913 000
10705034358314 K112913 000

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