Who is the manufacturer of INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING?

Smith & Nephew, Inc. filed the 510(k) submission for INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING (K872624).

What is the FDA product code for INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING?

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

What is the regulatory pathway for INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING?

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

Who can help prepare an FDA 510(k) submission like INTRASITE INTERACTIVE HYDROCOLLOID WOUND 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.

INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING

K872624 · Smith & Nephew, Inc. · FRO · Jul 29, 1987 · SU

Device Facts

Record ID	K872624
Device Name	INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING
Applicant	Smith & Nephew, Inc.
Product Code	FRO · SU
Decision Date	Jul 29, 1987
Decision	SN
Submission Type	Traditional
Device Class	Class U

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