MICROSPAN INSEMINATION SYSTEM— 510(k) K970750

Name: FDA 510(k) clearance K970750
Creator: U.S. Food and Drug Administration
Published: 1997-05-05

Substantially Equivalent

Imagyn Medical, Inc.

FDA 510(k) clearance K970750 for MICROSPAN INSEMINATION SYSTEM, Substantially Equivalent on 1997-05-05. Applicant: Imagyn Medical, Inc.. Device class: 2.

Clearance details

Applicant: Imagyn Medical, Inc.
Product code: Code MFD
Device class: Class 2
Regulation: 21 CFR 884.5250
Advisory panel: Obstetrics/Gynecology
Date received: 1997-03-03
Decision date: 1997-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Niguel, CA, US

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