FOCUS FLUID

Accessories, Retractor, Dental

HEMATOLOGY MARKETING ASSOC.

The following data is part of a premarket notification filed by Hematology Marketing Assoc. with the FDA for Focus Fluid.

Pre-market Notification Details

Device IDK830187
510k NumberK830187
Device Name:FOCUS FLUID
ClassificationAccessories, Retractor, Dental
Applicant HEMATOLOGY MARKETING ASSOC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEIF  
CFR Regulation Number872.4565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-01-19
Decision Date1983-03-01

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