FDA 510(k), K062779, DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)

FDA 510(k), K062779, DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)

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510(K) Number: K062779
Device Name: DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)
Manufacturer: SID MATHUR
Device Classification Name: Laparoscope, General & Plastic Surgery
Regulation Number: GCJ
Classification Product Code: KXA
Date Received: 09/18/2006
Decision Date: 10/05/2006
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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