FDA 510(k), K023789, O.B. TAMPONS

FDA 510(k), K023789, O.B. TAMPONS

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510(K) Number: K023789
Device Name: O.B. TAMPONS
Manufacturer: DIANA L.B. UHL
Device Classification Name: Tampon, Menstrual, Unscented
Regulation Number: HEB
Classification Product Code: KXA
Date Received: 11/13/2002
Decision Date: 12/06/2002
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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