ORICARE L2700

Light, Surgical, Ceiling Mounted

ORICARE, INC.

The following data is part of a premarket notification filed by Oricare, Inc. with the FDA for Oricare L2700.

Pre-market Notification Details

Device IDK122875
510k NumberK122875
Device Name:ORICARE L2700
ClassificationLight, Surgical, Ceiling Mounted
Applicant ORICARE, INC. 1900 AM DRIVE Quakertown,  PA  18951
ContactDavid T Jamison
CorrespondentDavid T Jamison
ORICARE, INC. 1900 AM DRIVE Quakertown,  PA  18951
Product CodeFSY  
CFR Regulation Number878.4580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-19
Decision Date2012-12-18
Summary:summary

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