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510(k) K896036

THE COMFORTABLE CANNULA by Comfortable Concepts Corp. — Product Code CAT

K896036 is an FDA 510(k) premarket notification submitted by Comfortable Concepts Corp. for the device "THE COMFORTABLE CANNULA". The FDA issued a decision of Substantially Equivalent on November 17, 1989. The device falls under product code CAT (Cannula, Nasal, Oxygen), a Class I device regulated under 21 CFR 868.5340.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1989
Date Received
October 17, 1989
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 for product code CAT

  • K011125 — NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA M (June 13, 2001)
  • K935533 — NASAL CANNULA (February 3, 1994)
  • 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)
  • K892435 — KENDALL CURITY OXYGEN NASAL CANNULA (June 12, 1989)

FDA data resources