MEDISCOPE— 510(k) K031436

Substantially Equivalent

Sometech Corporation

FDA 510(k) clearance K031436 for MEDISCOPE, Substantially Equivalent on 2003-12-19. Applicant: Sometech Corporation. Device class: 2.

Clearance details

Applicant: Sometech Corporation
Product code: Code HEX
Device class: Class 2
Regulation: 21 CFR 884.1630
Advisory panel: Obstetrics/Gynecology
Date received: 2003-05-06
Decision date: 2003-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Sometech Corporation

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