STRYKER LED LIGHTSOURCE

Light Source, Fiberoptic, Routine

STRYKER CORP.

The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Led Lightsource.

Pre-market Notification Details

Device IDK082813
510k NumberK082813
Device Name:STRYKER LED LIGHTSOURCE
ClassificationLight Source, Fiberoptic, Routine
Applicant STRYKER CORP. 5900 Optical Court San Jose,  CA  95138
ContactDesiree Crisolo
CorrespondentDesiree Crisolo
STRYKER CORP. 5900 Optical Court San Jose,  CA  95138
Product CodeFCW  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-24
Decision Date2008-12-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327051667 K082813 000
07613327051339 K082813 000
07613327051520 K082813 000
07613327051537 K082813 000
07613327051544 K082813 000
07613327051551 K082813 000
07613327051629 K082813 000
07613327051636 K082813 000
07613327051643 K082813 000
07613327051650 K082813 000
07613327051322 K082813 000

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