ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.— 510(k) K952470

Name: FDA 510(k) clearance K952470
Creator: U.S. Food and Drug Administration
Published: 1995-11-28

Substantially Equivalent

R-Group Intl.

FDA 510(k) clearance K952470 for ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II., Substantially Equivalent on 1995-11-28. Applicant: R-Group Intl.. Device class: 1.

Clearance details

Applicant: R-Group Intl.
Product code: Code GCD
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1995-05-26
Decision date: 1995-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

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