DUREX, RAMSES, SHEIK— 510(k) K952415

Name: FDA 510(k) clearance K952415
Creator: U.S. Food and Drug Administration
Published: 1996-07-15

Substantially Equivalent

London International U.S. Holdings, Inc.

FDA 510(k) clearance K952415 for DUREX, RAMSES, SHEIK, Substantially Equivalent on 1996-07-15. Applicant: London International U.S. Holdings, Inc.. Device class: 2.

Clearance details

Applicant: London International U.S. Holdings, Inc.
Product code: Code LTZ
Device class: Class 2
Regulation: 21 CFR 884.5310
Advisory panel: Obstetrics/Gynecology
Date received: 1995-05-23
Decision date: 1996-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sarasota, FL, US

Download summary PDF View on FDA.gov ↗

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