PESSARY FLEXIBLE SILICONE NICHOLS— 510(k) K920633

Name: FDA 510(k) clearance K920633
Creator: U.S. Food and Drug Administration
Published: 1995-11-08

Substantially Equivalent

Bioteque America, Inc.

FDA 510(k) clearance K920633 for PESSARY FLEXIBLE SILICONE NICHOLS, Substantially Equivalent on 1995-11-08. Applicant: Bioteque America, Inc.. Device class: 2.

Clearance details

Applicant: Bioteque America, Inc.
Product code: Code KXP
Device class: Class 2
Regulation: 21 CFR 884.3900
Advisory panel: Obstetrics/Gynecology
Date received: 1992-02-12
Decision date: 1995-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Langhorne, PA, US

Download summary PDF View on FDA.gov ↗

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K920747 — PESSARY FLEXIBLE SILICONE DONUT RING1994-08-29

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