COLPOSCOPES AND ACCESSORIES— 510(k) K940094

Name: FDA 510(k) clearance K940094
Creator: U.S. Food and Drug Administration
Published: 1995-04-25

Substantially Equivalent

Leisegang Medical, Inc.

FDA 510(k) clearance K940094 for COLPOSCOPES AND ACCESSORIES, Substantially Equivalent on 1995-04-25. Applicant: Leisegang Medical, Inc.. Device class: 2.

Clearance details

Applicant: Leisegang Medical, Inc.
Product code: Code HEX
Device class: Class 2
Regulation: 21 CFR 884.1630
Advisory panel: Obstetrics/Gynecology
Date received: 1994-01-07
Decision date: 1995-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

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