TERM GUARD II DEVICE— 510(k) K893770

Substantially Equivalent

Tokos Medical Corp.

FDA 510(k) clearance K893770 for TERM GUARD II DEVICE, Substantially Equivalent on 1989-11-03. Applicant: Tokos Medical Corp.. Device class: 2.

Clearance details

Applicant: Tokos Medical Corp.
Product code: Code HFM
Device class: Class 2
Regulation: 21 CFR 884.2720
Advisory panel: Obstetrics/Gynecology
Date received: 1989-05-22
Decision date: 1989-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, 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.