PRO-TEC DISPOSABLE SHARPS CONTAINERS

Needle, Hypodermic, Single Lumen

PRO-TEC CONTAINERS, INC.

The following data is part of a premarket notification filed by Pro-tec Containers, Inc. with the FDA for Pro-tec Disposable Sharps Containers.

Pre-market Notification Details

Device IDK942179
510k NumberK942179
Device Name:PRO-TEC DISPOSABLE SHARPS CONTAINERS
ClassificationNeedle, Hypodermic, Single Lumen
Applicant PRO-TEC CONTAINERS, INC. 108 COMMERCE ST. STE 105 Lake Mary,  FL  32746
ContactTreesa Spencer
CorrespondentTreesa Spencer
PRO-TEC CONTAINERS, INC. 108 COMMERCE ST. STE 105 Lake Mary,  FL  32746
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-04
Decision Date1994-12-02

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