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510(k) K991625

KOMET XK-95 PERFORATOR MOTOR (MI-102) by Komet Medical — Product Code HBB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1999
Date Received
May 11, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Drill, Pneumatic
Device Class
Class II
Regulation Number
882.4370
Review Panel
NE
Submission Type

Other clearances by Komet Medical

  • K984035 — XK-95 HIGH SPEED MOTOR DRILL SYSTEM (June 3, 1999)
  • K943758 — SURGICAL BUR (August 22, 1994)

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