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510(k) K935533

NASAL CANNULA by Puritas Health Care, Inc. — Product Code CAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1994
Date Received
November 16, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Nasal, Oxygen
Device Class
Class I
Regulation Number
868.5340
Review Panel
AN
Submission Type

Other clearances by Puritas Health Care, Inc.

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  • K935600 — TRACHEAL SUCTION CATHETER (May 10, 1994)
  • K935531 — OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP (May 5, 1994)
  • K940074 — Y-TYPE BLOOD ADMINISTRATION SET (April 21, 1994)
  • K940054 — MEASURED VOLUME SOLUTION ADMINISTRATION SET (April 15, 1994)
  • K940055 — MULTISET (April 15, 1994)
  • K935583 — SUCTION SET, TRACHAEL (April 11, 1994)
  • K940056 — WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM (April 4, 1994)
  • K935532 — TRANSFER SET (April 4, 1994)

Other clearances for product code CAT

  • K011125 — NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA M (June 13, 2001)
  • K922397 — 4 SURE TM NASAL OXYGEN CANNULA (March 18, 1993)
  • K921496 — SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED (August 14, 1992)
  • K920573 — CANNULA NASAL OXYGEN (August 11, 1992)
  • K913421 — NASAL OXYGEN CANNULA, 81585, 81587 & 81589 (October 18, 1991)
  • K912197 — SKIN SAVER(TM) TUBING HOLDER, MODEL 467 (August 20, 1991)
  • K911740 — SALTER LABS NEONATAL NASAL OXYGEN CANNULA (July 24, 1991)
  • K902420 — CATHETER, NASAL, OXYGEN (April 17, 1991)
  • K896036 — THE COMFORTABLE CANNULA (November 17, 1989)
  • K892435 — KENDALL CURITY OXYGEN NASAL CANNULA (June 12, 1989)