FDA 510(k), K072647, GLYCERIN & PARABEN FREE ASTROGLIDE

FDA 510(k), K072647, GLYCERIN & PARABEN FREE ASTROGLIDE

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510(K) Number: K072647
Device Name: GLYCERIN & PARABEN FREE ASTROGLIDE
Manufacturer: ROBERT DE ARMOND
Device Classification Name: Lubricant, Personal
Regulation Number: NUC
Classification Product Code: KXA
Date Received: 09/19/2007
Decision Date: 01/25/2008
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Obstetrics/Gynecology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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