FDA 510(k)

STRAITH ORAL AIRWAY

K-Number: K831078 · 1983-06-24

ApplicantSurgical Technology Laboratories, Inc.

Decision Date1983-06-24

Product CodeCAE

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

STRAITH ORAL AIRWAY is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Technology Laboratories, Inc.. It received FDA 510(k) clearance on 1983-06-24 under 510(k) number K831078. 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 STRAITH ORAL AIRWAY?

STRAITH ORAL AIRWAY is a medical device that received FDA 510(k) clearance on 1983-06-24. The listed applicant is Surgical Technology Laboratories, Inc.. The 510(k) number is K831078.

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

STRAITH ORAL AIRWAY received FDA 510(k) clearance on 1983-06-24, under 510(k) number K831078.

Who is the listed applicant for STRAITH ORAL AIRWAY?

The FDA 510(k) record lists Surgical Technology Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRAITH ORAL AIRWAY?

The FDA product code for STRAITH ORAL AIRWAY is CAE.

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Other records listing Surgical Technology Laboratories, Inc. as applicant

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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.