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510(k) K955616

MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE by Misten Medical Corp. — Product Code ETD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1996
Date Received
December 11, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tympanostomy
Device Class
Class II
Regulation Number
874.3880
Review Panel
EN
Submission Type

Other clearances by Misten Medical Corp.

  • K962163 — MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL (July 25, 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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