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510(k) K901279

CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAY by Chatham Industries — Product Code BTQ

K901279 is an FDA 510(k) premarket notification submitted by Chatham Industries for the device "CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAY". The FDA issued a decision of Substantially Equivalent on March 28, 1990. The device falls under product code BTQ (Airway, Nasopharyngeal), a Class I device regulated under 21 CFR 868.5100.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1990
Date Received
March 19, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airway, Nasopharyngeal
Device Class
Class I
Regulation Number
868.5100
Review Panel
AN
Submission Type

Other clearances for product code BTQ

  • K940320 — AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS (September 19, 1995)
  • K921353 — NASOPHARYNGEAL AIRWAY (June 11, 1992)
  • K911784 — NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY (September 23, 1991)
  • K903618 — ROBERTAZZI NASOPHARYNGEAL AIRWAY (January 8, 1991)
  • K900456 — POLAMEDCO NASOPAHARYNGEAL AIRWAY (April 19, 1990)
  • K883668 — SUNDERLAND NASAL TUBE (November 21, 1988)
  • K873949 — RORERTAZZI NASOPHARYNGEAL AIRWAY (October 20, 1987)
  • K871673 — NASOPHARYNGEAL AIRWAY (June 15, 1987)
  • K853162 — STERILE NASOPHARYNGEAL AIRWAY (August 6, 1985)
  • K850644 — NASOPHARYNGEAL AIRWAY-ROBERTAZZI (March 21, 1985)

FDA data resources