Question 1

Who is the manufacturer of WATER JEL STERILE GEL-SOAKED BURN DRESSING?

Accepted Answer

Trilling Medical Technologies, Inc. filed the 510(k) submission for WATER JEL STERILE GEL-SOAKED BURN DRESSING (K900516).

Question 2

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

Accepted Answer

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

Question 3

When was WATER JEL STERILE GEL-SOAKED BURN DRESSING cleared by the FDA?

Accepted Answer

Mar 19, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for WATER JEL STERILE GEL-SOAKED BURN DRESSING?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like WATER JEL STERILE GEL-SOAKED BURN 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	K900516
Device Name	WATER JEL STERILE GEL-SOAKED BURN DRESSING
Applicant	Trilling Medical Technologies, Inc.
Product Code	FRO · SU
Decision Date	Mar 19, 1990
Decision	SESE
Submission Type	Traditional
Device Class	Class U

WATER JEL STERILE GEL-SOAKED BURN DRESSING

Device Facts