Question 1

Who is the manufacturer of AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.?

Accepted Answer

Smith & Nephew, Inc. filed the 510(k) submission for AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA. (K881048).

Question 2

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

Accepted Answer

FRO. as a Class U device in the SU panel.

Question 3

When was AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA. cleared by the FDA?

Accepted Answer

Mar 21, 1988 (decision: SESE).

Question 4

What is the regulatory pathway for AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K881048
Device Name	AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.
Applicant	Smith & Nephew, Inc.
Product Code	FRO · SU
Decision Date	Mar 21, 1988
Decision	SESE
Submission Type	Traditional
Device Class	Class U

AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.

Device Facts