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510(k) K911364

SPOON FORCEPS, 11MM by Northgate Technologies, Inc. — Product Code LQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1991
Date Received
March 28, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Biliary Mechanical
Device Class
Class II
Regulation Number
876.4500
Review Panel
GU
Submission Type

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  • K942544 — GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS (November 22, 1994)
  • K943191 — MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR (August 29, 1994)
  • K905552 — LAPAROLITH (December 17, 1991)
  • K911477 — LAPAROSCOPIC BASKET FLEXIBLE AND RIGID (August 14, 1991)
  • K903529 — BML SERIES (January 23, 1991)
  • K902170 — SOEHENDRA LITHOTRIPSY SET (July 25, 1990)
  • K860863 — ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER (May 15, 1986)