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FDA 510(k)

WOUNDFOAM 4 X 4

K-Number: K953070 · 1995-09-08

ApplicantTrinity Laboratories, Inc.
Decision Date1995-09-08
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

WOUNDFOAM 4 X 4 is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Laboratories, Inc.. It received FDA 510(k) clearance on 1995-09-08 under 510(k) number K953070. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WOUNDFOAM 4 X 4?

WOUNDFOAM 4 X 4 is a medical device that received FDA 510(k) clearance on 1995-09-08. The listed applicant is Trinity Laboratories, Inc.. The 510(k) number is K953070.

When did WOUNDFOAM 4 X 4 receive FDA 510(k) clearance?

WOUNDFOAM 4 X 4 received FDA 510(k) clearance on 1995-09-08, under 510(k) number K953070.

Who is the listed applicant for WOUNDFOAM 4 X 4?

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

What is the FDA product code for WOUNDFOAM 4 X 4?

The FDA product code for WOUNDFOAM 4 X 4 is KMF.

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Other records listing Trinity Laboratories, Inc. as applicant

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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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