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510(k) K894050

MODIFIED DECANNULATION STOPPER by Premier Medical — Product Code JOH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1989
Date Received
June 7, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Tracheostomy And Tube Cuff
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
Submission Type

Other clearances by Premier Medical

  • K896303 — BIOPSY PUNCH (February 13, 1990)
  • K884418 — PREMIER DIE-TRAK ARTICULATOR (November 14, 1988)

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