BIOPSY-DIGIT— 510(k) K990192

Substantially Equivalent

Sitco, Inc.

FDA 510(k) clearance K990192 for BIOPSY-DIGIT, Substantially Equivalent on 1999-03-12. Applicant: Sitco, Inc.. Device class: 2.

Clearance details

Applicant: Sitco, Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 1999-01-21
Decision date: 1999-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, 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.