UVA HEX UNIT— 510(k) K813307

Substantially Equivalent

Sun Shanty, Inc.

FDA 510(k) clearance K813307 for UVA HEX UNIT, Substantially Equivalent on 1981-12-31. Applicant: Sun Shanty, Inc.. Device class: 2.

Clearance details

Applicant: Sun Shanty, Inc.
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 1981-11-23
Decision date: 1981-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.