AMSINO DISPOSABLE VIGINAL SPECULUM— 510(k) K951528

Name: FDA 510(k) clearance K951528
Creator: U.S. Food and Drug Administration
Published: 1995-05-11

Substantially Equivalent

Amsino Intl., Inc.

FDA 510(k) clearance K951528 for AMSINO DISPOSABLE VIGINAL SPECULUM, Substantially Equivalent on 1995-05-11. Applicant: Amsino Intl., Inc.. Device class: 2.

Clearance details

Applicant: Amsino Intl., Inc.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1995-04-03
Decision date: 1995-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: City Of Industry, 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.