GBJ · Prosthesis, Adhesive, External
General, Plastic Surgery · 21 CFR 878.3750 · Class 1
Overview
| Product Code | GBJ |
|---|---|
| Device Name | Prosthesis, Adhesive, External |
| Regulation | 21 CFR 878.3750 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
An external prosthesis adhesive is a silicone-type adhesive intended to be used to fasten to the body an external aesthetic restoration prosthesis, such as an artificial nose.
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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K934970 | DUET | Trulife , Ltd. | Dec 10, 1993 | SESE |
| K810282 | OPERATING TABLE ACCESSORY CLAMP | Minnesota Scientific, Inc. | Feb 26, 1981 | SESE |
| K790946 | GORDON IVS INTRAVENOUS STABILIZER | Whitman Medical Corp. | Jun 5, 1979 | SESE |
| K790186 | PROTECTIVSTABILIZER | Jelco Laboratories | Feb 26, 1979 | SESE |
Top Applicants
- Jelco Laboratories — 1 clearance
- Minnesota Scientific, Inc. — 1 clearance
- Trulife , Ltd. — 1 clearance
- Whitman Medical Corp. — 1 clearance
