SPECULITE DISPOSABLE VAGINAL LIGHT— 510(k) K853257

Name: FDA 510(k) clearance K853257
Creator: U.S. Food and Drug Administration
Published: 1985-12-27

Substantially Equivalent

Trylon Associates, Ltd.

FDA 510(k) clearance K853257 for SPECULITE DISPOSABLE VAGINAL LIGHT, Substantially Equivalent on 1985-12-27. Applicant: Trylon Associates, Ltd.. Device class: 2.

Clearance details

Applicant: Trylon Associates, Ltd.
Product code: Code HIC
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1985-08-02
Decision date: 1985-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Harbor City, CA, US

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