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510(k) K802322

MODEL SD-1 DISINTEGRATOR by Northgate Research, Inc. — Product Code FFK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1980
Date Received
September 23, 1980
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)
  • K891252 — UROLOGICAL LOOP RETRIEVERS (March 22, 1989)
  • K891253 — UROLOGICAL GRASPING FORCEPS (March 22, 1989)
  • K891254 — UROLOGICAL STONE BASKET (March 22, 1989)
  • K864904 — 3F ELECTRODE (February 10, 1987)
  • K852874 — 5F ELECTRODE(LITHOTRIPTOR) (August 21, 1985)

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