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510(k) K943108

MEDNEXT MICRO-DRILL by Mednext, Inc. — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1994
Date Received
June 29, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device Class
Class II
Regulation Number
874.4250
Review Panel
EN
Submission Type

Other clearances by Mednext, Inc.

  • K983092 — TRITON HUDSON CHUCK ATTACHMENT (November 6, 1998)
  • K972308 — MEDNEXT 1000 DRILL (August 20, 1997)
  • K970023 — MEDNEXT SURGICAL BUR (February 28, 1997)
  • K935861 — MEDNEXT BUR (May 3, 1994)
  • K935584 — MEDNEXT BUR (February 22, 1994)
  • K926547 — MEDNEXT 1000 BONE DISSECTING SYSTEM (July 22, 1993)

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