IMC SURGICAL GOWNS

Gown, Surgical

INTL. MEDSURG CONNECTION, INC.

The following data is part of a premarket notification filed by Intl. Medsurg Connection, Inc. with the FDA for Imc Surgical Gowns.

Pre-market Notification Details

Device IDK052550
510k NumberK052550
Device Name:IMC SURGICAL GOWNS
ClassificationGown, Surgical
Applicant INTL. MEDSURG CONNECTION, INC. 935 N. PLUM GROVE RD. STE. F Schaumburg,  IL  60173 -4770
ContactManny Gupta
CorrespondentManny Gupta
INTL. MEDSURG CONNECTION, INC. 935 N. PLUM GROVE RD. STE. F Schaumburg,  IL  60173 -4770
Product CodeFYA  
CFR Regulation Number878.4040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-16
Decision Date2005-11-17
Summary:summary

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