DISPOSABLE NEEDLE HOLDER

Instrument, Surgical, Disposable

MEDCARE PRODUCTS

The following data is part of a premarket notification filed by Medcare Products with the FDA for Disposable Needle Holder.

Pre-market Notification Details

Device IDK831665
510k NumberK831665
Device Name:DISPOSABLE NEEDLE HOLDER
ClassificationInstrument, Surgical, Disposable
Applicant MEDCARE PRODUCTS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKDC  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-23
Decision Date1983-09-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.