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FDA 510(k)

BREATHING MOUTHPIECE

K-Number: K893791 · 1989-06-23

ApplicantDiemolding Corp.
Decision Date1989-06-23
Product CodeBYP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BREATHING MOUTHPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Diemolding Corp.. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K893791. 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 BREATHING MOUTHPIECE?

BREATHING MOUTHPIECE is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Diemolding Corp.. The 510(k) number is K893791.

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

BREATHING MOUTHPIECE received FDA 510(k) clearance on 1989-06-23, under 510(k) number K893791.

Who is the listed applicant for BREATHING MOUTHPIECE?

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

What is the FDA product code for BREATHING MOUTHPIECE?

The FDA product code for BREATHING MOUTHPIECE is BYP.

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Other records listing Diemolding Corp. 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.

K962749THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PORT/MOUTHPIECE, RESISTOR/PORTK961455MEDSHIELD/AEROCHAMBERK902713ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANSK902114CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITORK900754RESPIREX 2K781759RESCAL

View all 12 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.K872037AEROCHAMBERMonaghan Medical Corp.K865093SAFE-T-SHIELD MOUTHPIECEMedi Nuclear Corp., Inc.K863049INHALATION AIDBoehringer Ingelheim Pharmaceuticals, Inc.K862788MP-4400 MOUTHPIECE-FLANGE SEALMedipart Jerry Alexander

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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