CHALLENGER SUNRISE— 510(k) K853248

Substantially Equivalent

Challenge Products, Inc.

FDA 510(k) clearance K853248 for CHALLENGER SUNRISE, Substantially Equivalent on 1985-09-13. Applicant: Challenge Products, Inc.. Device class: 2.

Clearance details

Applicant: Challenge Products, Inc.
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 1985-07-31
Decision date: 1985-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lancashire England Bb1 9s, GB

Download summary PDF View on FDA.gov ↗

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