WELCON LIGHT HANDLE

Light, Surgical, Accessories

WELCON, INC.

The following data is part of a premarket notification filed by Welcon, Inc. with the FDA for Welcon Light Handle.

Pre-market Notification Details

Device IDK894397
510k NumberK894397
Device Name:WELCON LIGHT HANDLE
ClassificationLight, Surgical, Accessories
Applicant WELCON, INC. 99 HARTFORD AVE. Providence,  RI  02909
ContactRichard P Welch
CorrespondentRichard P Welch
WELCON, INC. 99 HARTFORD AVE. Providence,  RI  02909
Product CodeFTA  
CFR Regulation Number878.4580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-20
Decision Date1989-08-10

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