REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181— 510(k) K893223

Name: FDA 510(k) clearance K893223
Creator: U.S. Food and Drug Administration
Published: 1989-06-09

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K893223 for REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181, Substantially Equivalent on 1989-06-09. Applicant: Helena Laboratories. Device class: 1.

Clearance details

Applicant: Helena Laboratories
Product code: Code JHO
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1989-04-27
Decision date: 1989-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

Download summary PDF View on FDA.gov ↗

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