REGENESIS MODEL 42— 510(k) K972093

Substantially Equivalent

Regenesis Biomedical, Inc.

FDA 510(k) clearance K972093 for REGENESIS MODEL 42, Substantially Equivalent on 1997-10-21. Applicant: Regenesis Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Regenesis Biomedical, Inc.
Product code: Code ILX
Device class: Class 2
Regulation: 21 CFR 890.5290
Advisory panel: Physical Medicine
Date received: 1997-06-04
Decision date: 1997-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, 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.