CLESTRACLEAN(R) ROOM AIR PURIFIER— 510(k) K932803

Name: FDA 510(k) clearance K932803
Creator: U.S. Food and Drug Administration
Published: 1994-05-12

Substantially Equivalent

Clestra Cleanroom Technology, Inc.

FDA 510(k) clearance K932803 for CLESTRACLEAN(R) ROOM AIR PURIFIER, Substantially Equivalent on 1994-05-12. Applicant: Clestra Cleanroom Technology, Inc.. Device class: 2.

Clearance details

Applicant: Clestra Cleanroom Technology, Inc.
Product code: Code FRA
Device class: Class 2
Regulation: 21 CFR 880.6500
Advisory panel: General Hospital
Date received: 1993-06-09
Decision date: 1994-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Syracuse, NY, 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.