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510(k) K960421

SINUSCAN 102/SINUSPRINT by Ferguson Medical — Product Code LWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1997
Date Received
January 29, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasound, Sinus
Device Class
Class II
Regulation Number
892.1560
Review Panel
EN
Submission Type

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  • 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)

Other clearances for product code LWI

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  • K874081 — ENTERSCAN (December 31, 1987)