DELUXE KNEE IMMOBILIZER(UNIVERSAL)

Joint, Knee, External Brace

WARM & FORM, ORTHOPEDIC MATERIALS

The following data is part of a premarket notification filed by Warm & Form, Orthopedic Materials with the FDA for Deluxe Knee Immobilizer(universal).

Pre-market Notification Details

Device IDK823658
510k NumberK823658
Device Name:DELUXE KNEE IMMOBILIZER(UNIVERSAL)
ClassificationJoint, Knee, External Brace
Applicant WARM & FORM, ORTHOPEDIC MATERIALS 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeITQ  
CFR Regulation Number890.3475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-06
Decision Date1982-12-30

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