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

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

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

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

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

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

Who can help prepare an FDA 510(k) submission like WATER JEL STERILE GEL-SOAKED BURN DRESSING?

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.

WATER JEL STERILE GEL-SOAKED BURN DRESSING

K900516 · Trilling Medical Technologies, Inc. · FRO · Mar 19, 1990 · SU

Device Facts

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

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