FDA 510(k)

CUSTOM DRESSING TRAY-WET TO DRY/MASS.

K-Number: K802385 · 1980-11-12

ApplicantAmerican Medical Disposable, Inc.

Decision Date1980-11-12

Product CodeFPX

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

CUSTOM DRESSING TRAY-WET TO DRY/MASS. is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Disposable, Inc.. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802385. The device is classified under product code FPX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSTOM DRESSING TRAY-WET TO DRY/MASS.?

CUSTOM DRESSING TRAY-WET TO DRY/MASS. is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is American Medical Disposable, Inc.. The 510(k) number is K802385.

When did CUSTOM DRESSING TRAY-WET TO DRY/MASS. receive FDA 510(k) clearance?

CUSTOM DRESSING TRAY-WET TO DRY/MASS. received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802385.

Who is the listed applicant for CUSTOM DRESSING TRAY-WET TO DRY/MASS.?

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

What is the FDA product code for CUSTOM DRESSING TRAY-WET TO DRY/MASS.?

The FDA product code for CUSTOM DRESSING TRAY-WET TO DRY/MASS. is FPX.

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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.