Product Code: MZR FDA class 1 21 CFR 880.5240

Topical Approximation System

General Hospital

The Topical Approximation System is a general hospital device used to bring wound edges together and maintain approximation during healing, functioning as a type of wound closure system applied topically to the skin surface. Classified as FDA Class 1, it is subject to general controls under regulation 880.5240 (General Hospital specialty). This low-risk, non-implanted wound closure device requires only general controls.

510(k)s
0
FEI Numbers
15
Registration Numbers
15
Unique Applicants
0
Years Active

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