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510(k) K781808

SLICK SET, CUFFED by Polamedco, Inc. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1978
Date Received
October 23, 1978
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)
  • K920900 — POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES (March 18, 1992)
  • K900456 — POLAMEDCO NASOPAHARYNGEAL AIRWAY (April 19, 1990)
  • K900457 — CUFFED LINDER NASOTRACHEAL AIRWAY (April 16, 1990)
  • K894516 — VISOSHIELD(TM), SURGICAL EYE PROTECTOR (September 12, 1989)

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