KGT · Drape, Adhesive, Aerosol
General, Plastic Surgery · 21 CFR 878.4380 · Class 1
Overview
| Product Code | KGT |
|---|---|
| Device Name | Drape, Adhesive, Aerosol |
| Regulation | 21 CFR 878.4380 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A drape adhesive is a device intended to be placed on the skin to attach a surgical drape.
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 § 878.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K851612 | DERMA PREP | Mowbray Co., Inc. | May 3, 1985 | SESE |
Top Applicants
- Mowbray Co., Inc. — 1 clearance
