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FDA 510(k)

PLASTIC MOUTH BARRIER HSV-I

K-Number: K853266 · 1985-10-29

ApplicantWestmark Enterprises, Inc.
Decision Date1985-10-29
Product CodeBYP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PLASTIC MOUTH BARRIER HSV-I is the device name listed in this FDA 510(k) record. The listed applicant is Westmark Enterprises, Inc.. It received FDA 510(k) clearance on 1985-10-29 under 510(k) number K853266. 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 PLASTIC MOUTH BARRIER HSV-I?

PLASTIC MOUTH BARRIER HSV-I is a medical device that received FDA 510(k) clearance on 1985-10-29. The listed applicant is Westmark Enterprises, Inc.. The 510(k) number is K853266.

When did PLASTIC MOUTH BARRIER HSV-I receive FDA 510(k) clearance?

PLASTIC MOUTH BARRIER HSV-I received FDA 510(k) clearance on 1985-10-29, under 510(k) number K853266.

Who is the listed applicant for PLASTIC MOUTH BARRIER HSV-I?

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

What is the FDA product code for PLASTIC MOUTH BARRIER HSV-I?

The FDA product code for PLASTIC MOUTH BARRIER HSV-I is BYP.

Related Clinical Trials

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Other records listing Westmark Enterprises, 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.

K871403MODIFIED C.P.R. MICROSHIELDK860780PLASTIC MOUTH BARRIER HCV-E

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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