HARKEN ASSURE SELF-SEAL STERILIZATION POUCH— 510(k) K945055

Name: FDA 510(k) clearance K945055
Creator: U.S. Food and Drug Administration
Published: 1994-12-14

Substantially Equivalent

Harken Products, Inc.

FDA 510(k) clearance K945055 for HARKEN ASSURE SELF-SEAL STERILIZATION POUCH, Substantially Equivalent on 1994-12-14. Applicant: Harken Products, Inc.. Device class: 2.

Clearance details

Applicant: Harken Products, Inc.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1994-10-14
Decision date: 1994-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irwindall, CA, US

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