ORTHOTIC FABRICATION ACCESSORIES

Orthosis, Limb Brace

FRED SAMMONS, INC.

The following data is part of a premarket notification filed by Fred Sammons, Inc. with the FDA for Orthotic Fabrication Accessories.

Pre-market Notification Details

Device IDK821640
510k NumberK821640
Device Name:ORTHOTIC FABRICATION ACCESSORIES
ClassificationOrthosis, Limb Brace
Applicant FRED SAMMONS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeIQI  
CFR Regulation Number890.3475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-06-03
Decision Date1982-06-11

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