FDA 510(k)

DECUBITUS CARE ABSORBENT DRESSING

K-Number: K832407 · 1984-01-19

Decision Date1984-01-19

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

DECUBITUS CARE ABSORBENT DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is American Pharmaseal Div. Ahsc. It received FDA 510(k) clearance on 1984-01-19 under 510(k) number K832407. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DECUBITUS CARE ABSORBENT DRESSING?

DECUBITUS CARE ABSORBENT DRESSING is a medical device that received FDA 510(k) clearance on 1984-01-19. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K832407.

When did DECUBITUS CARE ABSORBENT DRESSING receive FDA 510(k) clearance?

DECUBITUS CARE ABSORBENT DRESSING received FDA 510(k) clearance on 1984-01-19, under 510(k) number K832407.

Who is the listed applicant for DECUBITUS CARE ABSORBENT DRESSING?

The FDA 510(k) record lists American Pharmaseal Div. Ahsc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DECUBITUS CARE ABSORBENT DRESSING?

The FDA product code for DECUBITUS CARE ABSORBENT DRESSING is FRO. This falls under the Anesthesiology category.

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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.