DISPOSABLE SYRINGES AND DISPOSABLE NEEDLES

Syringe, Piston

MYCO MEDICAL SUPPLIES, INC.

The following data is part of a premarket notification filed by Myco Medical Supplies, Inc. with the FDA for Disposable Syringes And Disposable Needles.

Pre-market Notification Details

Device IDK945225
510k NumberK945225
Device Name:DISPOSABLE SYRINGES AND DISPOSABLE NEEDLES
ClassificationSyringe, Piston
Applicant MYCO MEDICAL SUPPLIES, INC. 6640 PORTSMOUTH LN. Raleigh,  NC  27615
ContactSanjiv K Kumar
CorrespondentSanjiv K Kumar
MYCO MEDICAL SUPPLIES, INC. 6640 PORTSMOUTH LN. Raleigh,  NC  27615
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-26
Decision Date1995-01-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
18903347051898 K945225 000

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