ROMFLEX— 510(k) K905718

Substantially Equivalent

Paraflex Corp.

FDA 510(k) clearance K905718 for ROMFLEX, Substantially Equivalent on 1991-02-19. Applicant: Paraflex Corp.. Device class: 1.

Clearance details

Applicant: Paraflex Corp.
Product code: Code BXB
Device class: Class 1
Regulation: 21 CFR 890.5380
Advisory panel: Physical Medicine
Date received: 1990-12-21
Decision date: 1991-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clinton, TN, 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.