Topical Approximation System
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.
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Basic Information
- Product Code
- MZR
- Device Class
- FDA class 1
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.