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FDA 510(k)

ABCO ISOLATION MASKS

K-Number: K851312 · 1985-05-01

ApplicantAbco Dealers, Inc.
Decision Date1985-05-01
Product Code
DecisionSubstantially Equivalent

Device Summary

ABCO ISOLATION MASKS is the device name listed in this FDA 510(k) record. The listed applicant is Abco Dealers, Inc.. It received FDA 510(k) clearance on 1985-05-01 under 510(k) number K851312. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABCO ISOLATION MASKS?

ABCO ISOLATION MASKS is a medical device that received FDA 510(k) clearance on 1985-05-01. The listed applicant is Abco Dealers, Inc.. The 510(k) number is K851312.

When did ABCO ISOLATION MASKS receive FDA 510(k) clearance?

ABCO ISOLATION MASKS received FDA 510(k) clearance on 1985-05-01, under 510(k) number K851312.

Who is the listed applicant for ABCO ISOLATION MASKS?

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

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Other records listing Abco Dealers, Inc. as applicant

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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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