DRYSTAR, MODEL 4500M

Camera, Multi Format, Radiological

AGFA CORP.

The following data is part of a premarket notification filed by Agfa Corp. with the FDA for Drystar, Model 4500m.

Pre-market Notification Details

Device IDK012941
510k NumberK012941
Device Name:DRYSTAR, MODEL 4500M
ClassificationCamera, Multi Format, Radiological
Applicant AGFA CORP. 12300 TWINBROOK PKWY,STE 625 Rockville,  MD  20852
ContactT. Whit Athey
CorrespondentT. Whit Athey
AGFA CORP. 12300 TWINBROOK PKWY,STE 625 Rockville,  MD  20852
Product CodeLMC  
CFR Regulation Number892.2040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-31
Decision Date2001-11-29
Summary:summary

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