ACCESS HEMAWIPE— 510(k) K843601

Substantially Equivalent

Medtech Products, Inc.

FDA 510(k) clearance K843601 for ACCESS HEMAWIPE, Substantially Equivalent on 1985-01-04. Applicant: Medtech Products, Inc.. Device class: 2.

Clearance details

Applicant: Medtech Products, Inc.
Product code: Code KHE
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 1984-09-12
Decision date: 1985-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.