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510(k) K920900

POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES by Polamedco, Inc. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1992
Date Received
February 26, 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 Polamedco, Inc.

  • K983000 — CRICOTHYROTOMY TUBE (October 27, 1999)
  • K954383 — SURELOC CIRCUIT CONNECTOR (December 22, 1995)
  • K953793 — INTROSCOPE (November 29, 1995)
  • K950713 — AIRGUIDE STYLETTE (May 17, 1995)
  • K933596 — GASTRIC, CATHETER, IRRIGATION & ASPIRATION (February 13, 1995)
  • K950380 — FLEXTITIP STYLETTE (February 10, 1995)
  • K900456 — POLAMEDCO NASOPAHARYNGEAL AIRWAY (April 19, 1990)
  • K900457 — CUFFED LINDER NASOTRACHEAL AIRWAY (April 16, 1990)
  • K894516 — VISOSHIELD(TM), SURGICAL EYE PROTECTOR (September 12, 1989)
  • K881496 — LINDER NASOTRACHEAL AIRWAY (May 31, 1988)

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  • K223130 — Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP ( (August 30, 2023)
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