MZR · Topical Approximation System
General Hospital · 21 CFR 880.5240 · Class 1
Overview
| Product Code | MZR |
|---|---|
| Device Name | Topical Approximation System |
| Regulation | 21 CFR 880.5240 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
