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FDA 510(k)

MP-4400 MOUTHPIECE-FLANGE SEAL

K-Number: K862788 · 1986-08-01

ApplicantMedipart Jerry Alexander
Decision Date1986-08-01
Product CodeBYP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MP-4400 MOUTHPIECE-FLANGE SEAL is the device name listed in this FDA 510(k) record. The listed applicant is Medipart Jerry Alexander. It received FDA 510(k) clearance on 1986-08-01 under 510(k) number K862788. 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 MP-4400 MOUTHPIECE-FLANGE SEAL?

MP-4400 MOUTHPIECE-FLANGE SEAL is a medical device that received FDA 510(k) clearance on 1986-08-01. The listed applicant is Medipart Jerry Alexander. The 510(k) number is K862788.

When did MP-4400 MOUTHPIECE-FLANGE SEAL receive FDA 510(k) clearance?

MP-4400 MOUTHPIECE-FLANGE SEAL received FDA 510(k) clearance on 1986-08-01, under 510(k) number K862788.

Who is the listed applicant for MP-4400 MOUTHPIECE-FLANGE SEAL?

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

What is the FDA product code for MP-4400 MOUTHPIECE-FLANGE SEAL?

The FDA product code for MP-4400 MOUTHPIECE-FLANGE SEAL is BYP.

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Other records listing Medipart Jerry Alexander 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.

K896885DISPOSABLE RESPIRTORY KIT (MP-200)K896125MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133MK896475DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELDK896124MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133K896476DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELDK894138MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD

View all 49 devices →

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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