CARELET SAFETY LANCET

Lancet, Blood

GAINOR MEDICAL EUROPE, LTD.

The following data is part of a premarket notification filed by Gainor Medical Europe, Ltd. with the FDA for Carelet Safety Lancet.

Pre-market Notification Details

Device IDK931828
510k NumberK931828
Device Name:CARELET SAFETY LANCET
ClassificationLancet, Blood
Applicant GAINOR MEDICAL EUROPE, LTD. P.O. BOX 353 Mcdonough,  GA  30253 -0353
ContactMark J Gainor
CorrespondentMark J Gainor
GAINOR MEDICAL EUROPE, LTD. P.O. BOX 353 Mcdonough,  GA  30253 -0353
Product CodeFMK  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-08
Decision Date1993-10-15

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