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FDA 510(k)

WELLCOGEN GROUP B

K-Number: K820069 · 1982-02-18

ApplicantBurroughs Wellcome Co.
Decision Date1982-02-18
Product CodeGTZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

WELLCOGEN GROUP B is the device name listed in this FDA 510(k) record. The listed applicant is Burroughs Wellcome Co.. It received FDA 510(k) clearance on 1982-02-18 under 510(k) number K820069. The device is classified under product code GTZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELLCOGEN GROUP B?

WELLCOGEN GROUP B is a medical device that received FDA 510(k) clearance on 1982-02-18. The listed applicant is Burroughs Wellcome Co.. The 510(k) number is K820069.

When did WELLCOGEN GROUP B receive FDA 510(k) clearance?

WELLCOGEN GROUP B received FDA 510(k) clearance on 1982-02-18, under 510(k) number K820069.

Who is the listed applicant for WELLCOGEN GROUP B?

The FDA 510(k) record lists Burroughs Wellcome Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WELLCOGEN GROUP B?

The FDA product code for WELLCOGEN GROUP B is GTZ.

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Other records listing Burroughs Wellcome Co. as applicant

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Related Devices (Code: GTZ)

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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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