DAYSTAR SELECTRA & SELECTRA/ORBITER

Light, Surgical, Ceiling Mounted

CASTLE CO.

The following data is part of a premarket notification filed by Castle Co. with the FDA for Daystar Selectra & Selectra/orbiter.

Pre-market Notification Details

Device IDK780666
510k NumberK780666
Device Name:DAYSTAR SELECTRA & SELECTRA/ORBITER
ClassificationLight, Surgical, Ceiling Mounted
Applicant CASTLE CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFSY  
CFR Regulation Number878.4580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-03-10
Decision Date1978-04-27

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