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FDA 510(k)

GENADYNE A4-XLR8 WOUND VACUUM SYSTEM

K-Number: K090638 · 2009-04-29

ApplicantGenadyne Biotechnologies, Inc.
Decision Date2009-04-29
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GENADYNE A4-XLR8 WOUND VACUUM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Genadyne Biotechnologies, Inc.. It received FDA 510(k) clearance on 2009-04-29 under 510(k) number K090638. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENADYNE A4-XLR8 WOUND VACUUM SYSTEM?

GENADYNE A4-XLR8 WOUND VACUUM SYSTEM is a medical device that received FDA 510(k) clearance on 2009-04-29. The listed applicant is Genadyne Biotechnologies, Inc.. The 510(k) number is K090638.

When did GENADYNE A4-XLR8 WOUND VACUUM SYSTEM receive FDA 510(k) clearance?

GENADYNE A4-XLR8 WOUND VACUUM SYSTEM received FDA 510(k) clearance on 2009-04-29, under 510(k) number K090638.

Who is the listed applicant for GENADYNE A4-XLR8 WOUND VACUUM SYSTEM?

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

What is the FDA product code for GENADYNE A4-XLR8 WOUND VACUUM SYSTEM?

The FDA product code for GENADYNE A4-XLR8 WOUND VACUUM SYSTEM is OMP.

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Related Devices (Code: OMP)

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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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