MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE— 510(k) K891986

Name: FDA 510(k) clearance K891986
Creator: U.S. Food and Drug Administration
Published: 1989-12-29

Substantially Equivalent

Mark One Healthcare Products

FDA 510(k) clearance K891986 for MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE, Substantially Equivalent on 1989-12-29. Applicant: Mark One Healthcare Products. Device class: 1.

Clearance details

Applicant: Mark One Healthcare Products
Product code: Code KME
Device class: Class 1
Regulation: 21 CFR 880.6060
Advisory panel: General Hospital
Date received: 1989-03-28
Decision date: 1989-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Runnemede, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.