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510(k) K923559

STERI-CATH MDI by Concord/Portex — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1993
Date Received
July 17, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Other clearances by Concord/Portex

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  • K923127 — NEEDLE-PRO CARTRIDGE (April 29, 1993)
  • K923910 — HEAT MOISTURE CONDENSER (January 26, 1993)
  • K922749 — LOW PROFILE TRACHEOSTOMY TUBE (September 2, 1992)
  • K922445 — VACU-PRO (August 12, 1992)
  • K915452 — ANESTHESIA BREATHING CIRCUIT (February 14, 1992)
  • K911809 — NEW-VENT (August 26, 1991)
  • K912124 — TRACHEOSTOMY TUBE AND CUFF (August 16, 1991)

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