SHARPSAFE, CAT. NO. 4126

Needle, Hypodermic, Single Lumen

SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Smiths Industries Medical Systems, Inc. with the FDA for Sharpsafe, Cat. No. 4126.

Pre-market Notification Details

Device IDK935776
510k NumberK935776
Device Name:SHARPSAFE, CAT. NO. 4126
ClassificationNeedle, Hypodermic, Single Lumen
Applicant SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene,  NH  03431
ContactTimothy J Talcott
CorrespondentTimothy J Talcott
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. 15 KIT ST. Keene,  NH  03431
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-03
Decision Date1994-02-28

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