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510(k) K820709

AIRWAYS by Seven Harvest Intl. Import & Export — Product Code CAE

K820709 is an FDA 510(k) premarket notification submitted by Seven Harvest Intl. Import & Export for the device "AIRWAYS". The FDA issued a decision of Substantially Equivalent on June 25, 1982. The device falls under product code CAE (Airway, Oropharyngeal, Anesthesiology), a Class I device regulated under 21 CFR 868.5110. Seven Harvest Intl. Import & Export has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1982
Date Received
March 18, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airway, Oropharyngeal, Anesthesiology
Device Class
Class I
Regulation Number
868.5110
Review Panel
AN
Submission Type

Other clearances by Seven Harvest Intl. Import & Export

  • K940793 — DOUBLE TRACH SWIVEL CONNECTOR (July 1, 1994)
  • K823506 — NASAL CANNULA (December 9, 1982)
  • K823141 — OXYGEN MASKS (November 29, 1982)
  • K823142 — OXYGEN TUBINGS (November 29, 1982)
  • K823143 — BUBBLE HUMIDIFIERS (November 29, 1982)
  • K813074 — CONNECTORS & ADAPTERS (December 31, 1981)

Other clearances for product code CAE

  • K130304 — LMA FAMILY OF AIRWAYS (May 30, 2014)
  • K033189 — KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 30 (May 4, 2004)
  • K033186 — KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 (April 14, 2004)
  • K021634 — KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 (January 9, 2003)
  • K955721 — CUFFED OROPHARYNGEAL AIRWAY (COPA) (March 28, 1997)
  • K960240 — RUSCH OPTOSAFE (April 19, 1996)
  • K950613 — KEISEI (February 14, 1996)
  • K953400 — GUEDEL AIRWAY (October 24, 1995)
  • K933760 — STB GUEDEL AIRWAY (March 23, 1994)
  • K936134 — BERMAN AIRWAY (January 28, 1994)

FDA data resources