STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI.— 510(k) K894399

Name: FDA 510(k) clearance K894399
Creator: U.S. Food and Drug Administration
Published: 1989-09-11

Substantially Equivalent

Pymah Corp.

FDA 510(k) clearance K894399 for STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI., Substantially Equivalent on 1989-09-11. Applicant: Pymah Corp.. Device class: 2.

Clearance details

Applicant: Pymah Corp.
Product code: Code FRC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 1989-07-17
Decision date: 1989-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

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