GYNECOLOGIC EXAMINATION KIT— 510(k) K894489

Name: FDA 510(k) clearance K894489
Creator: U.S. Food and Drug Administration
Published: 1989-10-05

Substantially Equivalent

A & A Medical, Inc.

FDA 510(k) clearance K894489 for GYNECOLOGIC EXAMINATION KIT, Substantially Equivalent on 1989-10-05. Applicant: A & A Medical, Inc.. Device class: 2.

Clearance details

Applicant: A & A Medical, Inc.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1989-07-20
Decision date: 1989-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branford, CT, US

Download summary PDF View on FDA.gov ↗

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