SPIRAL— 510(k) K920514

Substantially Equivalent

Thornton Associates, Inc.

FDA 510(k) clearance K920514 for SPIRAL, Substantially Equivalent on 1994-02-22. Applicant: Thornton Associates, Inc.. Device class: 2.

Clearance details

Applicant: Thornton Associates, Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1992-02-04
Decision date: 1994-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rowayton, CT, 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.