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510(k) K050384

KAPP BARI-RING, MODEL KS-BR-2005 by Kapp Surgical Instrument, Inc. — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2006
Date Received
February 15, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Radiographic, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

Other clearances by Kapp Surgical Instrument, Inc.

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  • K072216 — KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 (November 9, 2007)
  • K050657 — MONDEAL CONTOUR HO SYSTEM (August 8, 2005)
  • K050655 — MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005 (August 8, 2005)
  • K033930 — KAPP CUSTOM ULNAR HEAD WRIST IMPLANT (July 28, 2004)
  • K030237 — KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT (August 29, 2003)
  • K844177 — COSGROVE MITRAL VALVE RETRACTOR (November 8, 1984)
  • K843368 — KAPP SPINAL BUTTON (September 12, 1984)

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