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FDA 510(k)

BERMAN INTUBATING/PHARYNGEAL AIRWAY

K-Number: K913680 · 1991-10-10

ApplicantChain Plastics Operations, Inc.
Decision Date1991-10-10
Product CodeCAE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BERMAN INTUBATING/PHARYNGEAL AIRWAY is the device name listed in this FDA 510(k) record. The listed applicant is Chain Plastics Operations, Inc.. It received FDA 510(k) clearance on 1991-10-10 under 510(k) number K913680. 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 BERMAN INTUBATING/PHARYNGEAL AIRWAY?

BERMAN INTUBATING/PHARYNGEAL AIRWAY is a medical device that received FDA 510(k) clearance on 1991-10-10. The listed applicant is Chain Plastics Operations, Inc.. The 510(k) number is K913680.

When did BERMAN INTUBATING/PHARYNGEAL AIRWAY receive FDA 510(k) clearance?

BERMAN INTUBATING/PHARYNGEAL AIRWAY received FDA 510(k) clearance on 1991-10-10, under 510(k) number K913680.

Who is the listed applicant for BERMAN INTUBATING/PHARYNGEAL AIRWAY?

The FDA 510(k) record lists Chain Plastics Operations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BERMAN INTUBATING/PHARYNGEAL AIRWAY?

The FDA product code for BERMAN INTUBATING/PHARYNGEAL AIRWAY is CAE.

Related Clinical Trials

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Related Devices (Code: CAE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 MedicalK960240RUSCH OPTOSAFERusch Intl.K950613KEISEIKeisei (Usa) Co., Ltd.

Official Source

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

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