FDA 510(k)

AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.

K-Number: K881048 · 1988-03-21

Decision Date1988-03-21

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA. is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 1988-03-21 under 510(k) number K881048. 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 AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.?

AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA. is a medical device that received FDA 510(k) clearance on 1988-03-21. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K881048.

When did AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA. receive FDA 510(k) clearance?

AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA. received FDA 510(k) clearance on 1988-03-21, under 510(k) number K881048.

Who is the listed applicant for AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.?

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

What is the FDA product code for AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.?

The FDA product code for AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA. 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.