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510(k) K843368

KAPP SPINAL BUTTON by Kapp Surgical Instrument, Inc. — Product Code HTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1984
Date Received
August 28, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Washer, Bolt Nut
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • 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)

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