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FDA 510(k)

E-Z-GUARD MOUTHPIECE

K-Number: K853402 · 1985-10-23

ApplicantE-Z-Em, Inc.
Decision Date1985-10-23
Product CodeBYP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

E-Z-GUARD MOUTHPIECE is the device name listed in this FDA 510(k) record. The listed applicant is E-Z-Em, Inc.. It received FDA 510(k) clearance on 1985-10-23 under 510(k) number K853402. 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 E-Z-GUARD MOUTHPIECE?

E-Z-GUARD MOUTHPIECE is a medical device that received FDA 510(k) clearance on 1985-10-23. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K853402.

When did E-Z-GUARD MOUTHPIECE receive FDA 510(k) clearance?

E-Z-GUARD MOUTHPIECE received FDA 510(k) clearance on 1985-10-23, under 510(k) number K853402.

Who is the listed applicant for E-Z-GUARD MOUTHPIECE?

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

What is the FDA product code for E-Z-GUARD MOUTHPIECE?

The FDA product code for E-Z-GUARD MOUTHPIECE is BYP.

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Other records listing E-Z-Em, 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.

K071378MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIESK062449EMPOWERMR INJECTOR SYSTEM, MODEL 9730K063029EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900K053008E-Z-EM ENDOSCOPIC CO2 REGULATORK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)K031571EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825

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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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