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FDA 510(k)

MOUTHPIECE SEAL

K-Number: K761297 · 1977-01-03

ApplicantOem Medical Div.
Decision Date1977-01-03
Product CodeBYP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MOUTHPIECE SEAL is the device name listed in this FDA 510(k) record. The listed applicant is Oem Medical Div.. It received FDA 510(k) clearance on 1977-01-03 under 510(k) number K761297. 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 MOUTHPIECE SEAL?

MOUTHPIECE SEAL is a medical device that received FDA 510(k) clearance on 1977-01-03. The listed applicant is Oem Medical Div.. The 510(k) number is K761297.

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

MOUTHPIECE SEAL received FDA 510(k) clearance on 1977-01-03, under 510(k) number K761297.

Who is the listed applicant for MOUTHPIECE SEAL?

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

What is the FDA product code for MOUTHPIECE SEAL?

The FDA product code for MOUTHPIECE SEAL is BYP.

Related Clinical Trials

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Other records listing Oem Medical Div. 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.

K924570OEM MULTI-VAC POWERED SUCTION PUMPK925893OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUITK922748GUEDEL AIRWAYK811855SKIN SCRUB KITS

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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