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510(k) K083358

LUBRICANO-ULTRASOUND by Farco Pharma GmbH — Product Code MUI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2009
Date Received
October 14, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Coupling, Ultrasound
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Farco Pharma GmbH

  • K081990 — LUBRICANO STERILE GEL (December 5, 2008)

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  • K221999 — Ultrasound Transmission Gels (August 30, 2022)
  • K211691 — Ultrast Gel (December 22, 2021)
  • K190591 — Safergel Sterile Ultrasound Gel (October 4, 2019)
  • K181363 — EcoVue Sterile and Non-Sterile Ultrasound Gels (June 13, 2018)
  • K163026 — Ultra/Phonic Scanning Gel (January 9, 2018)
  • K163027 — Ultra/Phonic Free Conductivity Gel (January 9, 2018)
  • K163023 — Other-Sonic Transmission Gel (January 8, 2018)