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FDA 510(k)

WATER JEL STERILE GEL-SOAKED BURN DRESSING

K-Number: K892360 · 1989-06-05

ApplicantPfizer, Inc.
Decision Date1989-06-05
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

WATER JEL STERILE GEL-SOAKED BURN DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer, Inc.. It received FDA 510(k) clearance on 1989-06-05 under 510(k) number K892360. 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 WATER JEL STERILE GEL-SOAKED BURN DRESSING?

WATER JEL STERILE GEL-SOAKED BURN DRESSING is a medical device that received FDA 510(k) clearance on 1989-06-05. The listed applicant is Pfizer, Inc.. The 510(k) number is K892360.

When did WATER JEL STERILE GEL-SOAKED BURN DRESSING receive FDA 510(k) clearance?

WATER JEL STERILE GEL-SOAKED BURN DRESSING received FDA 510(k) clearance on 1989-06-05, under 510(k) number K892360.

Who is the listed applicant for WATER JEL STERILE GEL-SOAKED BURN DRESSING?

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

What is the FDA product code for WATER JEL STERILE GEL-SOAKED BURN DRESSING?

The FDA product code for WATER JEL STERILE GEL-SOAKED BURN DRESSING is FRO. This falls under the Anesthesiology category.

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Related Devices (Code: FRO)

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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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