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510(k) K894490

STERILE ULTRASOUND TRANSMISSION GEL by Swedish Trade Council USA — Product Code JOT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1989
Date Received
July 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Gel, Electrosurgical
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Other clearances by Swedish Trade Council USA

  • K903034 — RENALYZER PRX 90 (March 13, 1991)

Other clearances for product code JOT

  • K923647 — RFG-DGP DISPOSABLE GROUNDING PADS (November 9, 1992)
  • K905545 — ULTRASOUND TRANSMISSION GEL (March 29, 1991)
  • K904418 — ULTRASOUND COUPLING GEL (February 11, 1991)
  • K901217 — TRIA-SONIC ULTRA SOUND TRANSMISSION GEL (June 22, 1990)
  • K884503 — ULTRASONIC TRANSMISSION GEL (February 13, 1989)
  • K872519 — STERILIZED OMNI GEL (August 3, 1987)
  • K871565 — ULTRASOUND TRANSDUCER GEL, STERILE (July 15, 1987)
  • K800933 — R2 ELECTROSURG. RETURN ELECT. #225ETC. (May 20, 1980)