KYW · Container, Liquid Medication, Graduated
General Hospital · 21 CFR 880.6430 · Class 1
Overview
| Product Code | KYW |
|---|---|
| Device Name | Container, Liquid Medication, Graduated |
| Regulation | 21 CFR 880.6430 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication.
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. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K800213 | PHARMACY ADDITIVE SYRINGE SET | Cutter Laboratories, Inc. | Feb 26, 1980 | SESE |
| K791345 | MEDICINE CUP | General Clinical Plastics Corp. | Aug 3, 1979 | SESE |
Top Applicants
- Cutter Laboratories, Inc. — 1 clearance
- General Clinical Plastics Corp. — 1 clearance
