ULTICARE DISPOSABLE SYRINGE 3 ML/CC

Syringe, Piston

ULTIMED, INC.

The following data is part of a premarket notification filed by Ultimed, Inc. with the FDA for Ulticare Disposable Syringe 3 Ml/cc.

Pre-market Notification Details

Device IDK033794
510k NumberK033794
Device Name:ULTICARE DISPOSABLE SYRINGE 3 ML/CC
ClassificationSyringe, Piston
Applicant ULTIMED, INC. 188 SUQUAMISH WAY Laconner,  WA  98257
ContactEllen G Redding
CorrespondentEllen G Redding
ULTIMED, INC. 188 SUQUAMISH WAY Laconner,  WA  98257
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-05
Decision Date2003-12-30
Summary:summary

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