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510(k) K072216

KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 by Kapp Surgical Instrument, Inc. — Product Code NEU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2007
Date Received
August 9, 2007
Clearance Type
Special
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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  • K050384 — KAPP BARI-RING, MODEL KS-BR-2005 (January 13, 2006)
  • 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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