Question 1

Who is the manufacturer of TEGADERM PLUS TRANSPARENT DRESSING #952X?

Accepted Answer

3M Company filed the 510(k) submission for TEGADERM PLUS TRANSPARENT DRESSING #952X (K852750).

Question 2

What is the FDA product code for TEGADERM PLUS TRANSPARENT DRESSING #952X?

Accepted Answer

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

Question 3

When was TEGADERM PLUS TRANSPARENT DRESSING #952X cleared by the FDA?

Accepted Answer

Sep 19, 1985 (decision: SESD).

Question 4

What is the regulatory pathway for TEGADERM PLUS TRANSPARENT DRESSING #952X?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like TEGADERM PLUS TRANSPARENT DRESSING #952X?

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	K852750
Device Name	TEGADERM PLUS TRANSPARENT DRESSING #952X
Applicant	3M Company
Product Code	FRO · SU
Decision Date	Sep 19, 1985
Decision	SESD
Submission Type	Traditional
Device Class	Class U

TEGADERM PLUS TRANSPARENT DRESSING #952X

Device Facts