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FDA 510(k)

OWREN'S VERONAL BUFFERR

K-Number: K841523 · 1984-06-01

ApplicantDiatech, Inc.
Decision Date1984-06-01
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

OWREN'S VERONAL BUFFERR is the device name listed in this FDA 510(k) record. The listed applicant is Diatech, Inc.. It received FDA 510(k) clearance on 1984-06-01 under 510(k) number K841523. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OWREN'S VERONAL BUFFERR?

OWREN'S VERONAL BUFFERR is a medical device that received FDA 510(k) clearance on 1984-06-01. The listed applicant is Diatech, Inc.. The 510(k) number is K841523.

When did OWREN'S VERONAL BUFFERR receive FDA 510(k) clearance?

OWREN'S VERONAL BUFFERR received FDA 510(k) clearance on 1984-06-01, under 510(k) number K841523.

Who is the listed applicant for OWREN'S VERONAL BUFFERR?

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

What is the FDA product code for OWREN'S VERONAL BUFFERR?

The FDA product code for OWREN'S VERONAL BUFFERR is JPA.

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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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