EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL

Dryer, Film, Radiographic

G-C INTL. CORP.

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

Pre-market Notification Details

Device IDK902531
510k NumberK902531
Device Name:EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL
ClassificationDryer, Film, Radiographic
Applicant G-C INTL. CORP. 7830 E.REDFIELD RD. STE.12 (GC TELLS OF FIRM CLOSING) Scottsdale,  AZ  85260
ContactWilliam R Jacobs
CorrespondentWilliam R Jacobs
G-C INTL. CORP. 7830 E.REDFIELD RD. STE.12 (GC TELLS OF FIRM CLOSING) Scottsdale,  AZ  85260
Product CodeEGW  
CFR Regulation Number892.1900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-06-05
Decision Date1990-07-13

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