VISITEC NEEDLE RANGE (GENERAL HOSPITAL)

Needle, Hypodermic, Single Lumen

VISITEC CO.

The following data is part of a premarket notification filed by Visitec Co. with the FDA for Visitec Needle Range (general Hospital).

Pre-market Notification Details

Device IDK811966
510k NumberK811966
Device Name:VISITEC NEEDLE RANGE (GENERAL HOSPITAL)
ClassificationNeedle, Hypodermic, Single Lumen
Applicant VISITEC CO. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-07-10
Decision Date1981-07-23

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