FDA 510(k), K132325, GUIDOR BIORESORBABLE MATRIX BARRIER

FDA 510(k), K132325, GUIDOR BIORESORBABLE MATRIX BARRIER

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510(K) Number: K132325
Device Name: GUIDOR BIORESORBABLE MATRIX BARRIER
Manufacturer: DEBORAH L GRAYESKI
Device Classification Name: Barrier, Synthetic, Intraoral
Regulation Number: NPK
Classification Product Code: KXA
Date Received: 07/26/2013
Decision Date: 10/29/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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