OVR · Kit, First Aid, Talking
General, Plastic Surgery · 21 CFR 878.4014 · Class 1
Overview
| Product Code | OVR |
|---|---|
| Device Name | Kit, First Aid, Talking |
| Regulation | 21 CFR 878.4014 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K110625 | SAFETYMATE TALKING FIRST AID | Safetymate, Inc. | Jun 17, 2011 | SESE |
Top Applicants
- Safetymate, Inc. — 1 clearance
