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510(k) K903337

1.9 FRENCH LITHOTRIPTER ELECTRODE by Northgate Research, Inc. — Product Code FFK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1990
Date Received
July 25, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Electro-Hydraulic
Device Class
Class II
Regulation Number
876.4480
Review Panel
GU
Submission Type

Other clearances by Northgate Research, Inc.

  • K894704 — 2.5 FRENCH LITHOTRIPTOR ELECTRODE (October 18, 1989)
  • K891252 — UROLOGICAL LOOP RETRIEVERS (March 22, 1989)
  • K891254 — UROLOGICAL STONE BASKET (March 22, 1989)
  • K891253 — UROLOGICAL GRASPING FORCEPS (March 22, 1989)
  • K864904 — 3F ELECTRODE (February 10, 1987)
  • K852874 — 5F ELECTRODE(LITHOTRIPTOR) (August 21, 1985)
  • K802322 — MODEL SD-1 DISINTEGRATOR (November 10, 1980)

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  • K132795 — CYBERWAND STERILE PROBE SET (November 26, 2013)
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