IMAGYN FALLOPOSCOPY SYSTEM— 510(k) K963580

Name: FDA 510(k) clearance K963580
Creator: U.S. Food and Drug Administration
Published: 1997-01-31

Substantially Equivalent

Imagyn Medical, Inc.

FDA 510(k) clearance K963580 for IMAGYN FALLOPOSCOPY SYSTEM, Substantially Equivalent on 1997-01-31. Applicant: Imagyn Medical, Inc.. Device class: 2.

Clearance details

Applicant: Imagyn Medical, Inc.
Product code: Code MKO
Device class: Class 2
Regulation: 21 CFR 884.1690
Advisory panel: Obstetrics/Gynecology
Date received: 1996-09-06
Decision date: 1997-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Niguel, CA, US

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