COUNTER-ROTATION SYSTEM— 510(k) K821256

Substantially Equivalent

The Langer Group

FDA 510(k) clearance K821256 for COUNTER-ROTATION SYSTEM, Substantially Equivalent on 1982-06-23. Applicant: The Langer Group. Device class: 1.

Clearance details

Applicant: The Langer Group
Product code: Code ITN
Device class: Class 1
Regulation: 21 CFR 890.3675
Advisory panel: Physical Medicine
Date received: 1982-04-30
Decision date: 1982-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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