SPECTROLYSE FACTOR VII:C— 510(k) K934584

Substantially Equivalent

Meditech, Inc.

FDA 510(k) clearance K934584 for SPECTROLYSE FACTOR VII:C, Substantially Equivalent on 1993-12-06. Applicant: Meditech, Inc.. Device class: 2.

Clearance details

Applicant: Meditech, Inc.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1993-09-23
Decision date: 1993-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, 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.