EXAFLEX IMPRESSION MATERIAL

Material, Impression

G-C INTL. CORP.

The following data is part of a premarket notification filed by G-c Intl. Corp. with the FDA for Exaflex Impression Material.

Pre-market Notification Details

Device IDK812406
510k NumberK812406
Device Name:EXAFLEX IMPRESSION MATERIAL
ClassificationMaterial, Impression
Applicant G-C INTL. CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-08-21
Decision Date1981-10-06

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