OLYMPUS PK-TP ABSORBENT KIT— 510(k) K905038

Name: FDA 510(k) clearance K905038
Creator: U.S. Food and Drug Administration
Published: 1991-05-06

Substantially Equivalent

Fujirebio America, Inc.

FDA 510(k) clearance K905038 for OLYMPUS PK-TP ABSORBENT KIT, Substantially Equivalent on 1991-05-06. Applicant: Fujirebio America, Inc.. Device class: 2.

Clearance details

Applicant: Fujirebio America, Inc.
Product code: Code GMT
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1990-11-06
Decision date: 1991-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, NJ, US

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