VACLOK SYRINGE

Syringe, Piston

MERIT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Vaclok Syringe.

Pre-market Notification Details

Device IDK994253
510k NumberK994253
Device Name:VACLOK SYRINGE
ClassificationSyringe, Piston
Applicant MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan,  UT  84095
ContactChester Mccoy
CorrespondentChester Mccoy
MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan,  UT  84095
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-17
Decision Date2000-01-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30816777026706 K994253 000
00643169582224 K994253 000

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