STRATUM ESU— 510(k) K874719

Substantially Equivalent

Alternative Design Systems, Inc.

FDA 510(k) clearance K874719 for STRATUM ESU, Substantially Equivalent on 1988-02-16. Applicant: Alternative Design Systems, Inc.. Device class: 2.

Clearance details

Applicant: Alternative Design Systems, Inc.
Product code: Code JOS
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 1987-11-17
Decision date: 1988-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlstadt, 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.