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510(k) K760125

AIRWAY, ARGYLE NASOPHARYNGEAL by Sherwood Medical Industries — Product Code BTQ

K760125 is an FDA 510(k) premarket notification submitted by Sherwood Medical Industries for the device "AIRWAY, ARGYLE NASOPHARYNGEAL". The FDA issued a decision of Substantially Equivalent on July 19, 1976. The device falls under product code BTQ (Airway, Nasopharyngeal), a Class I device regulated under 21 CFR 868.5100. Sherwood Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1976
Date Received
June 28, 1976
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 by Sherwood Medical Industries

  • K801070 — SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES (July 21, 1980)
  • K801071 — LANCER GLUCOSE RATE REAGENT KIT (May 23, 1980)
  • K792013 — LANCER L-INA HUMAN REFERENCE SERUM (November 13, 1979)
  • K792014 — LANCER L-INA BUFFER, POLYMER, WASH SOLU (November 13, 1979)
  • K782077 — LANCER ICE CUBE (April 3, 1979)
  • K790523 — ARGYLE ESOPHAGEAL STETHOSCOPE (March 27, 1979)
  • K790196 — MONOJECT ARTERIAL BLOOD SAMPLING DEVICE (March 13, 1979)
  • K790197 — REAGENT KIT, LANCER GLUCOSE (March 12, 1979)
  • K781459 — MONOJECT SCALE MAGNIFIER (October 24, 1978)
  • K781060 — MONOJECT ENDOSSEOUS DENTAL IMPLANT (August 14, 1978)

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)
  • 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)

FDA data resources