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510(k) K962045

ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT by Mallinckrodt Medical — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1996
Date Received
May 28, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
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)
  • K962173 — SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES (October 4, 1996)
  • K955680 — SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED (March 13, 1996)
  • K954749 — MALLINCKRODT SHILEY 15MM CAP (January 24, 1996)

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