Newgel and Newgel Plus E

FDA 510(k) K041704 · Newmedical Technology, Inc.

Substantially Equivalent

510(k) numberK041704

Submission

Device name
Newgel and Newgel Plus E
Applicant
Newmedical Technology, Inc.
Northbrook, IL, US
Received
June 23, 2004
Decision date
October 17, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MDA – Elastomer, Silicone, For Scar Management
Device class
Class I (low risk)
Regulation
21 CFR 878.4025
Specialty
General, Plastic Surgery

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Questions and answers

When was Newgel and Newgel Plus E cleared by the FDA?

Newgel and Newgel Plus E (K041704) received a 510(k) decision of Substantially Equivalent on October 17, 2005, 481 days after the submission was received.

What is the product code of K041704?

The FDA product code is MDA – Elastomer, Silicone, For Scar Management, a Class I (low risk) device regulated under 21 CFR 878.4025.