FDA 510(k)

PHARMASEAL STERILE WOUND CARE DRESSING

K-Number: K884397 · 1988-12-27

Decision Date1988-12-27

Product CodeFRO

DecisionSubstantially Equivalent for Some Indications

Device Summary

PHARMASEAL STERILE WOUND CARE DRESSING 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 1988-12-27 under 510(k) number K884397. 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 for Some Indications.

Frequently Asked Questions

What is the PHARMASEAL STERILE WOUND CARE DRESSING?

PHARMASEAL STERILE WOUND CARE DRESSING is a medical device that received FDA 510(k) clearance on 1988-12-27. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K884397.

When did PHARMASEAL STERILE WOUND CARE DRESSING receive FDA 510(k) clearance?

PHARMASEAL STERILE WOUND CARE DRESSING received FDA 510(k) clearance on 1988-12-27, under 510(k) number K884397.

Who is the listed applicant for PHARMASEAL STERILE WOUND CARE DRESSING?

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 PHARMASEAL STERILE WOUND CARE DRESSING?

The FDA product code for PHARMASEAL STERILE WOUND CARE 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.