Who is the manufacturer of STERILE WOUND HYDROGEL DRESSING?

Renaissance Pharmaceutical, Inc. filed the 510(k) submission for STERILE WOUND HYDROGEL DRESSING (K941339).

What is the FDA product code for STERILE WOUND HYDROGEL DRESSING?

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

What is the regulatory pathway for STERILE WOUND HYDROGEL DRESSING?

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

Who can help prepare an FDA 510(k) submission like STERILE WOUND HYDROGEL 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.

STERILE WOUND HYDROGEL DRESSING

K941339 · Renaissance Pharmaceutical, Inc. · MGQ · Jun 10, 1994 · SU

Device Facts

Record ID	K941339
Device Name	STERILE WOUND HYDROGEL DRESSING
Applicant	Renaissance Pharmaceutical, Inc.
Product Code	MGQ · SU
Decision Date	Jun 10, 1994
Decision	SESE
Submission Type	Traditional
Device Class	Class U

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