VTEC-RPLA SEIKEN— 510(k) K981734

Substantially Equivalent

Denka Seiken'S

FDA 510(k) clearance K981734 for VTEC-RPLA SEIKEN, Substantially Equivalent on 1998-09-22. Applicant: Denka Seiken'S. Device class: 1.

Clearance details

Applicant: Denka Seiken'S
Product code: Code GNA
Device class: Class 1
Regulation: 21 CFR 866.3255
Advisory panel: Microbiology
Date received: 1998-05-18
Decision date: 1998-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

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