LIGHT, SURGICAL ACCESSORIES

Light, Surgical, Accessories

CHARLES POLO & CO., INC.

The following data is part of a premarket notification filed by Charles Polo & Co., Inc. with the FDA for Light, Surgical Accessories.

Pre-market Notification Details

Device IDK882132
510k NumberK882132
Device Name:LIGHT, SURGICAL ACCESSORIES
ClassificationLight, Surgical, Accessories
Applicant CHARLES POLO & CO., INC. P.O. BOX 227 W. Henrietta,  NY  14586
ContactJack Scoville
CorrespondentJack Scoville
CHARLES POLO & CO., INC. P.O. BOX 227 W. Henrietta,  NY  14586
Product CodeFTA  
CFR Regulation Number878.4580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-05-20
Decision Date1988-06-15

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