TEST ONE— 510(k) K894662

Substantially Equivalent

Primed Products, Inc.

FDA 510(k) clearance K894662 for TEST ONE, Substantially Equivalent on 1989-12-13. Applicant: Primed Products, Inc.. Device class: 2.

Clearance details

Applicant: Primed Products, Inc.
Product code: Code IKK
Device class: Class 2
Regulation: 21 CFR 890.1925
Advisory panel: Physical Medicine
Date received: 1989-07-24
Decision date: 1989-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Silver Spring, MD, 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.