Question 1

Who is the manufacturer of ELASTO-GEL OCCLUSIVE DRESSING?

Accepted Answer

Southwest Technologies, Inc. filed the 510(k) submission for ELASTO-GEL OCCLUSIVE DRESSING (K872165).

Question 2

What is the FDA product code for ELASTO-GEL OCCLUSIVE DRESSING?

Accepted Answer

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

Question 3

When was ELASTO-GEL OCCLUSIVE DRESSING cleared by the FDA?

Accepted Answer

Jun 26, 1987 (decision: SN).

Question 4

What is the regulatory pathway for ELASTO-GEL OCCLUSIVE DRESSING?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like ELASTO-GEL OCCLUSIVE DRESSING?

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	K872165
Device Name	ELASTO-GEL OCCLUSIVE DRESSING
Applicant	Southwest Technologies, Inc.
Product Code	FRO · SU
Decision Date	Jun 26, 1987
Decision	SN
Submission Type	Traditional
Device Class	Class U

ELASTO-GEL OCCLUSIVE DRESSING

Device Facts