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510(k) K945513

MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE by Mallinckrodt Medical — Product Code JOH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1995
Date Received
November 9, 1994
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 Mallinckrodt Medical

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  • K051416 — SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA (June 16, 2005)
  • K972258 — HI-CARE CLOSED SUCTION SYSTEM (December 29, 1997)
  • K971267 — SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EX (September 25, 1997)
  • K963732 — PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF A (June 26, 1997)
  • K955721 — CUFFED OROPHARYNGEAL AIRWAY (COPA) (March 28, 1997)
  • K965132 — HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES (March 20, 1997)
  • K962045 — ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT (November 26, 1996)
  • K962173 — SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES (October 4, 1996)
  • K955680 — SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED (March 13, 1996)

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