FLEXION MITTENS— 510(k) K771030

Substantially Equivalent

Stat Medical Corp.

FDA 510(k) clearance K771030 for FLEXION MITTENS, Substantially Equivalent on 1977-06-27. Applicant: Stat Medical Corp.. Device class: 1.

Clearance details

Applicant: Stat Medical Corp.
Product code: Code IOD
Device class: Class 1
Regulation: 21 CFR 890.5350
Advisory panel: Physical Medicine
Date received: 1977-06-09
Decision date: 1977-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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