POCKET COUNT OR SAFETCOUNT

Counter, Sponge, Surgical

SAGE PRODUCTS, INC.

The following data is part of a premarket notification filed by Sage Products, Inc. with the FDA for Pocket Count Or Safetcount.

Pre-market Notification Details

Device IDK972302
510k NumberK972302
Device Name:POCKET COUNT OR SAFETCOUNT
ClassificationCounter, Sponge, 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 CodeLWH  
CFR Regulation Number880.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-19
Decision Date1997-07-25
Summary:summary

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