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510(k) K930218

SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES by Concord/Portex — Product Code MAJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1993
Date Received
January 15, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous, Intraspinal, Short Term
Device Class
Class II
Regulation Number
868.5120
Review Panel
HO
Submission Type

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  • 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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  • K934939 — TEMPORARY SCREENING LEAD/ CATHETER KIT (May 24, 1995)
  • K911382 — IPI ALGO-LINE CATHETER (July 18, 1991)
  • K893766 — LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE (November 1, 1989)