TUBE-BANDAGE FOR HUMAN DIGITS 200— 510(k) K840107

Name: FDA 510(k) clearance K840107
Creator: U.S. Food and Drug Administration
Published: 1984-04-25

Substantially Equivalent

Zens Health Care Products

FDA 510(k) clearance K840107 for TUBE-BANDAGE FOR HUMAN DIGITS 200, Substantially Equivalent on 1984-04-25. Applicant: Zens Health Care Products. Device class: 1.

Clearance details

Applicant: Zens Health Care Products
Product code: Code FQM
Device class: Class 1
Regulation: 21 CFR 880.5075
Advisory panel: General Hospital
Date received: 1984-01-10
Decision date: 1984-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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