ECOCEL— 510(k) K083087

Substantially Equivalent

Polichem S.A

FDA 510(k) clearance K083087 for ECOCEL, Substantially Equivalent on 2009-08-07. Applicant: Polichem S.A. Device class: 1.

Clearance details

Applicant: Polichem S.A
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 2008-10-16
Decision date: 2009-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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