UNIVERSAL SLING, SLING & SWATHE

Sling, Arm

WARM & FORM, ORTHOPEDIC MATERIALS

The following data is part of a premarket notification filed by Warm & Form, Orthopedic Materials with the FDA for Universal Sling, Sling & Swathe.

Pre-market Notification Details

Device IDK823664
510k NumberK823664
Device Name:UNIVERSAL SLING, SLING & SWATHE
ClassificationSling, Arm
Applicant WARM & FORM, ORTHOPEDIC MATERIALS 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeILI  
CFR Regulation Number890.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-06
Decision Date1982-12-30

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