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510(k) K852874

5F ELECTRODE(LITHOTRIPTOR) by Northgate Research, Inc. — Product Code FFK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1985
Date Received
July 8, 1985
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.

  • K903337 — 1.9 FRENCH LITHOTRIPTER ELECTRODE (November 16, 1990)
  • K894704 — 2.5 FRENCH LITHOTRIPTOR ELECTRODE (October 18, 1989)
  • K891254 — UROLOGICAL STONE BASKET (March 22, 1989)
  • K891252 — UROLOGICAL LOOP RETRIEVERS (March 22, 1989)
  • K891253 — UROLOGICAL GRASPING FORCEPS (March 22, 1989)
  • K864904 — 3F ELECTRODE (February 10, 1987)
  • K802322 — MODEL SD-1 DISINTEGRATOR (November 10, 1980)

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