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510(k) K963894

SMARTGUIDE by Ferguson Medical — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1997
Date Received
September 27, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biopsy Needle
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type

Other clearances by Ferguson Medical

  • K033153 — DICOM THEATER (April 23, 2004)
  • K963794 — PUNCTURENEEDLE (March 19, 1998)
  • K962615 — TUMORLOCALIZER MRI (March 19, 1998)
  • K971813 — EMBLA (January 16, 1998)
  • K972219 — ORTHOPEDIC PLATE SYSTEM (November 20, 1997)
  • K972217 — ORTHOPEDIC SCREW SYSTEM (November 20, 1997)
  • K970819 — TARGOBEAM (July 14, 1997)
  • K970257 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTE (May 22, 1997)
  • K970258 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMOR (May 22, 1997)
  • K970280 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTE (May 22, 1997)

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