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510(k) K945438

EDI-BUR MICRODRILL SYSTEMS by Micromed Development Corp. — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1994
Date Received
October 20, 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 Micromed Development Corp.

  • K945105 — POLY/PLATINUM WIRE PISTON (May 14, 1996)
  • K945831 — DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT (January 20, 1995)
  • K945242 — NERVE MONITOR ELECTRODES/STIMULATOR PROBES (December 27, 1994)
  • K945108 — POLY PISTON (November 22, 1994)
  • K945107 — POLY-WIRE PISTON (November 22, 1994)
  • K945106 — MICROMED TOTAL REGULAR AND PARTIAL OFFSET (November 22, 1994)
  • K945104 — MICROMED PARTIAL REGULAR AND PARTIAL OFFSET (November 22, 1994)
  • K943848 — COLLAR BUTTON VENTURI VENT TUBE (September 16, 1994)
  • K943847 — BOBBIN STYLE VENTURI VENT TUBE (September 2, 1994)
  • K943849 — GROMMENT STYLE VENTURI TUBE (September 2, 1994)

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