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FDA 510(k)

BR-2 BIOREST

K-Number: K873920 · 1987-12-29

ApplicantBiorest, Inc.
Decision Date1987-12-29
Product CodeQJQ
Advisory CommitteeNE
DecisionSubstantially Equivalent for Some Indications

Device Summary

BR-2 BIOREST is the device name listed in this FDA 510(k) record. The listed applicant is Biorest, Inc.. It received FDA 510(k) clearance on 1987-12-29 under 510(k) number K873920. The device is classified under product code QJQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the BR-2 BIOREST?

BR-2 BIOREST is a medical device that received FDA 510(k) clearance on 1987-12-29. The listed applicant is Biorest, Inc.. The 510(k) number is K873920.

When did BR-2 BIOREST receive FDA 510(k) clearance?

BR-2 BIOREST received FDA 510(k) clearance on 1987-12-29, under 510(k) number K873920.

Who is the listed applicant for BR-2 BIOREST?

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

What is the FDA product code for BR-2 BIOREST?

The FDA product code for BR-2 BIOREST is QJQ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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