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510(k) K962163

MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL by Misten Medical Corp. — Product Code ERL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1996
Date Received
June 4, 1996
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 Misten Medical Corp.

  • K955616 — MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE (January 17, 1996)
  • K955615 — MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS (December 22, 1995)
  • K955613 — MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (December 22, 1995)

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