K-Y PERSONAL LUBRICANT— 510(k) K955648

Name: FDA 510(k) clearance K955648
Creator: U.S. Food and Drug Administration
Published: 1996-06-21

Substantially Equivalent

Ortho Pharmaceutical Corp.

FDA 510(k) clearance K955648 for K-Y PERSONAL LUBRICANT, Substantially Equivalent on 1996-06-21. Applicant: Ortho Pharmaceutical Corp.. Device class: 2.

Clearance details

Applicant: Ortho Pharmaceutical Corp.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1995-12-12
Decision date: 1996-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.