BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320)— 510(k) K972747

Name: FDA 510(k) clearance K972747
Creator: U.S. Food and Drug Administration
Published: 1998-01-09

Substantially Equivalent

Propper Mfg. Co., Inc.

FDA 510(k) clearance K972747 for BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320), Substantially Equivalent on 1998-01-09. Applicant: Propper Mfg. Co., Inc.. Device class: 2.

Clearance details

Applicant: Propper Mfg. Co., Inc.
Product code: Code FRC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 1997-07-23
Decision date: 1998-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Long Island, NY, US

Download summary PDF View on FDA.gov ↗

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