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FDA 510(k)

PLASTIC MOUTH BARRIER HCV-E

K-Number: K860780 · 1986-04-02

ApplicantWestmark Enterprises, Inc.
Decision Date1986-04-02
Product CodeCAE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PLASTIC MOUTH BARRIER HCV-E 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 1986-04-02 under 510(k) number K860780. The device is classified under product code CAE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLASTIC MOUTH BARRIER HCV-E?

PLASTIC MOUTH BARRIER HCV-E is a medical device that received FDA 510(k) clearance on 1986-04-02. The listed applicant is Westmark Enterprises, Inc.. The 510(k) number is K860780.

When did PLASTIC MOUTH BARRIER HCV-E receive FDA 510(k) clearance?

PLASTIC MOUTH BARRIER HCV-E received FDA 510(k) clearance on 1986-04-02, under 510(k) number K860780.

Who is the listed applicant for PLASTIC MOUTH BARRIER HCV-E?

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 HCV-E?

The FDA product code for PLASTIC MOUTH BARRIER HCV-E is CAE.

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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. MICROSHIELDK853266PLASTIC MOUTH BARRIER HSV-I

Related Devices (Code: CAE)

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.

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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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