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FDA 510(k)

BAKTERIETTE-VI-PAK

K-Number: K840719 · 1984-04-04

ApplicantGreat Lakes Intl.
Decision Date1984-04-04
Product CodeJTW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BAKTERIETTE-VI-PAK is the device name listed in this FDA 510(k) record. The listed applicant is Great Lakes Intl.. It received FDA 510(k) clearance on 1984-04-04 under 510(k) number K840719. The device is classified under product code JTW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAKTERIETTE-VI-PAK?

BAKTERIETTE-VI-PAK is a medical device that received FDA 510(k) clearance on 1984-04-04. The listed applicant is Great Lakes Intl.. The 510(k) number is K840719.

When did BAKTERIETTE-VI-PAK receive FDA 510(k) clearance?

BAKTERIETTE-VI-PAK received FDA 510(k) clearance on 1984-04-04, under 510(k) number K840719.

Who is the listed applicant for BAKTERIETTE-VI-PAK?

The FDA 510(k) record lists Great Lakes Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAKTERIETTE-VI-PAK?

The FDA product code for BAKTERIETTE-VI-PAK is JTW.

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Related Devices (Code: JTW)

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

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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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