FDA 510(k)

PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH

K-Number: K885045 · 1989-03-03

Decision Date1989-03-03

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1989-03-03 under 510(k) number K885045. 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 PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH?

PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH is a medical device that received FDA 510(k) clearance on 1989-03-03. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K885045.

When did PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH receive FDA 510(k) clearance?

PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH received FDA 510(k) clearance on 1989-03-03, under 510(k) number K885045.

Who is the listed applicant for PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH?

The FDA product code for PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH is FRO. This falls under the Anesthesiology category.

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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.