CAREJECT DISPOSABLE SYRINGE AND NEEDLE

Syringe, Piston

CAREWELL MEDIPRODUCTS, LTD.

The following data is part of a premarket notification filed by Carewell Mediproducts, Ltd. with the FDA for Careject Disposable Syringe And Needle.

Pre-market Notification Details

Device IDK931472
510k NumberK931472
Device Name:CAREJECT DISPOSABLE SYRINGE AND NEEDLE
ClassificationSyringe, Piston
Applicant CAREWELL MEDIPRODUCTS, LTD. 502 MANSAROVAR, 90 NEHRU PL. New Delhi,  IN 110019
ContactNand
CorrespondentNand
CAREWELL MEDIPRODUCTS, LTD. 502 MANSAROVAR, 90 NEHRU PL. New Delhi,  IN 110019
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-24
Decision Date1994-02-22

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