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FDA 510(k)

DISPOSABLE MOUTHPIECE

K-Number: K791537 · 1979-09-07

ApplicantHospitak, Inc.
Decision Date1979-09-07
Product CodeBYP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE MOUTHPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Hospitak, Inc.. It received FDA 510(k) clearance on 1979-09-07 under 510(k) number K791537. The device is classified under product code BYP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE MOUTHPIECE?

DISPOSABLE MOUTHPIECE is a medical device that received FDA 510(k) clearance on 1979-09-07. The listed applicant is Hospitak, Inc.. The 510(k) number is K791537.

When did DISPOSABLE MOUTHPIECE receive FDA 510(k) clearance?

DISPOSABLE MOUTHPIECE received FDA 510(k) clearance on 1979-09-07, under 510(k) number K791537.

Who is the listed applicant for DISPOSABLE MOUTHPIECE?

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

What is the FDA product code for DISPOSABLE MOUTHPIECE?

The FDA product code for DISPOSABLE MOUTHPIECE is BYP.

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Other records listing Hospitak, Inc. as applicant

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.

K955483TRACH MASK MODEL (245, 246)K954787ILLUMINATORK953620WARM N WET HMEF W/LUER ADAPTERK953619WARM N WET HME W/LUER ADAPTERK915750DISPOSABLE BACTERIAL BREATHNG FILTERK920842AEROSOL DELIVERY SYSTEMS

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Related Devices (Code: BYP)

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.

K955657NORTH STATE PLASTICS RESPIRATORY MOUTHPIECENorth State Plastics, Inc.K944512TRUZONE PFM DISPOSABLE MOUTHPIECEMonaghan Medical Corp.K893791BREATHING MOUTHPIECEDiemolding Corp.K872037AEROCHAMBERMonaghan Medical Corp.K865093SAFE-T-SHIELD MOUTHPIECEMedi Nuclear Corp., Inc.K863049INHALATION AIDBoehringer Ingelheim Pharmaceuticals, Inc.

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.

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