ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION— 510(k) K951063

Name: FDA 510(k) clearance K951063
Creator: U.S. Food and Drug Administration
Published: 1995-05-10

Substantially Equivalent

Pymah Corp.

FDA 510(k) clearance K951063 for ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION, Substantially Equivalent on 1995-05-10. Applicant: Pymah Corp.. Device class: 2.

Clearance details

Applicant: Pymah Corp.
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 1995-03-08
Decision date: 1995-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flemington, NJ, US

Download summary PDF View on FDA.gov ↗

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