FDA 510(k)

ORAL AIRWAY

K-Number: K891586 · 1989-05-11

Decision Date1989-05-11

Product CodeCAE

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ORAL AIRWAY is the device name listed in this FDA 510(k) record. The listed applicant is Dynarex Corp.. It received FDA 510(k) clearance on 1989-05-11 under 510(k) number K891586. The device is classified under product code CAE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORAL AIRWAY?

ORAL AIRWAY is a medical device that received FDA 510(k) clearance on 1989-05-11. The listed applicant is Dynarex Corp.. The 510(k) number is K891586.

When did ORAL AIRWAY receive FDA 510(k) clearance?

ORAL AIRWAY received FDA 510(k) clearance on 1989-05-11, under 510(k) number K891586.

Who is the listed applicant for ORAL AIRWAY?

The FDA 510(k) record lists Dynarex Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORAL AIRWAY?

The FDA product code for ORAL AIRWAY is CAE.

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Other records listing Dynarex Corp. as applicant

K052743DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 K052314DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE K012816DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 K012957TOWEL DRAPE, MODELS 4409, 4410 K012917DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B K991694DYNAREX DRAIN SPONGE

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Related Devices (Code: CAE)

K033189KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305King Systems Corp.K033186KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205King Systems Corp.K021634KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105King Systems Corp.K955721CUFFED OROPHARYNGEAL AIRWAY (COPA)Mallinckrodt Medical K960240RUSCH OPTOSAFERusch Intl.K950613KEISEIKeisei (Usa) Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.