RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC

Needle, Hypodermic, Single Lumen

SAGE PRODUCTS, INC.

The following data is part of a premarket notification filed by Sage Products, Inc. with the FDA for Resheather Device-metal Or Plastic, Resheater/ Needle Holder Device-plastic.

Pre-market Notification Details

Device IDK972705
510k NumberK972705
Device Name:RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC
ClassificationNeedle, Hypodermic, Single Lumen
Applicant SAGE PRODUCTS, INC. 815 TEK DR. Crystal Lake,  IL  60014 -8172
ContactKaren Pinto
CorrespondentKaren Pinto
SAGE PRODUCTS, INC. 815 TEK DR. Crystal Lake,  IL  60014 -8172
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-21
Decision Date1998-04-30
Summary:summary

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