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510(k) K911784

NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY by North American Sterilization & Packaging Co. — Product Code BTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1991
Date Received
April 22, 1991
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

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  • K962352 — HYDROGEL SKIN DRESSING (August 2, 1996)
  • K925588 — NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI (December 3, 1993)
  • K925593 — NORTEC STERILE WATER FOR DEVICE IRRIGATION (December 3, 1993)
  • K925161 — NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO (July 21, 1993)
  • K911865 — NORTEC CONNECTING TUBE SET (November 1, 1991)
  • K910691 — NORTEC URETERAL STENT (August 15, 1991)
  • K903156 — CONTROL-TIP CYSTOSCOPIC ELECTRODES (December 18, 1990)
  • K903162 — FLEXIBLE ENDOSCOPIC ELECTRODES (December 18, 1990)

Other clearances for product code BTQ

  • K940320 — AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS (September 19, 1995)
  • K921353 — NASOPHARYNGEAL AIRWAY (June 11, 1992)
  • K903618 — ROBERTAZZI NASOPHARYNGEAL AIRWAY (January 8, 1991)
  • K900456 — POLAMEDCO NASOPAHARYNGEAL AIRWAY (April 19, 1990)
  • K901279 — CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAY (March 28, 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)