PROCEDURE SPECIFIC KITS

Mask, Surgical

SAGE PRODUCTS, INC.

The following data is part of a premarket notification filed by Sage Products, Inc. with the FDA for Procedure Specific Kits.

Pre-market Notification Details

Device IDK964168
510k NumberK964168
Device Name:PROCEDURE SPECIFIC KITS
ClassificationMask, Surgical
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 CodeFXX  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-17
Decision Date1997-03-03
Summary:summary

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