GLO-SPEC— 510(k) K013817

Substantially Equivalent

Sol Weiss MD, Inc.

FDA 510(k) clearance K013817 for GLO-SPEC, Substantially Equivalent on 2001-12-21. Applicant: Sol Weiss MD, Inc.. Device class: 2.

Clearance details

Applicant: Sol Weiss MD, Inc.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2001-11-16
Decision date: 2001-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reseda, 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.