FDA 510(k), K973462, SOFTFORM FACIAL IMPLANT

FDA 510(k), K973462, SOFTFORM FACIAL IMPLANT

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510(K) Number: K973462
Device Name: SOFTFORM FACIAL IMPLANT
Manufacturer: JESSE KRAMER, PH.D
Device Classification Name: Mesh, Surgical, Polymeric
Regulation Number: FTL
Classification Product Code: KXA
Date Received: 09/12/1997
Decision Date: 11/24/1997
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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