FLASH GUARD PLASTIC VERSION

Tray, Surgical, Instrument

SPARCO, INC.

The following data is part of a premarket notification filed by Sparco, Inc. with the FDA for Flash Guard Plastic Version.

Pre-market Notification Details

Device IDK844286
510k NumberK844286
Device Name:FLASH GUARD PLASTIC VERSION
ClassificationTray, Surgical, Instrument
Applicant SPARCO, INC. P.O. BOX 20369 Castro Valley,  CA  94546
ContactBeverly J Sparks
CorrespondentBeverly J Sparks
SPARCO, INC. P.O. BOX 20369 Castro Valley,  CA  94546
Product CodeFSM  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-11-05
Decision Date1984-11-19

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