KELO-COTE TOPICAL GEL— 510(k) K002488

Name: FDA 510(k) clearance K002488
Creator: U.S. Food and Drug Administration
Published: 2001-01-05

Substantially Equivalent

Advanced Bio-Technologies, Inc.

FDA 510(k) clearance K002488 for KELO-COTE TOPICAL GEL, Substantially Equivalent on 2001-01-05. Applicant: Advanced Bio-Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Advanced Bio-Technologies, Inc.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 2000-08-14
Decision date: 2001-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cranage, Cheshire, GB

Download summary PDF View on FDA.gov ↗

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