STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137— 510(k) K052516

Name: FDA 510(k) clearance K052516
Creator: U.S. Food and Drug Administration
Published: 2005-10-03

Substantially Equivalent

Steritec Products, Inc.

FDA 510(k) clearance K052516 for STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137, Substantially Equivalent on 2005-10-03. Applicant: Steritec Products, Inc.. Device class: 2.

Clearance details

Applicant: Steritec Products, Inc.
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2005-09-14
Decision date: 2005-10-03
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Castle Rock, CO, US

Download summary PDF View on FDA.gov ↗

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