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510(k) K925781

DISPOSABLE CUFFED ENDOTRACHEAL TUBE by Coast Medical Corp. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1993
Date Received
November 12, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type

Other clearances by Coast Medical Corp.

  • K952243 — EXTENSION SET/I.V. SET (July 26, 1995)
  • K930929 — ESOPHAGEAL STETHOSCOPE (March 17, 1995)
  • K944729 — STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE (December 21, 1994)
  • K943270 — SURFACE TEMPERATURE PROBES (December 5, 1994)
  • K943495 — DISPOSABLE ESOPHAGEAL STETHOSCOPE (September 8, 1994)
  • K943110 — GAS SAMPLING INTERFACES (August 19, 1994)
  • K930930 — COAST MEDICAL, INC. RECTAL PROBE (February 25, 1994)
  • K925855 — DISPOSABLE UNCUFFED ENDOTRACHEAL TUBE (February 18, 1993)
  • K921077 — DISPOSABLE INTUBATION KITS (August 25, 1992)
  • K921353 — NASOPHARYNGEAL AIRWAY (June 11, 1992)

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