Snake Bite Suction Kit
FDA product code KYP · Class I (low risk) · 21 CFR 880.5740 · General Hospital
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K883839 | Nd:Yag Laser Spectacles, MST Model #YLS-5KYP · Traditional | Marlo Surgical Technology | 12/09/1988SE |
| K844048 | Dr. Hessel's Insect Poison RemoverKYP · Traditional | Medie Group | 01/23/1985SE |
| K842015 | Sawyer First Aid KitKYP · Traditional | Saffeta, Inc. | 07/06/1984SE |
| K831312 | Lopez-Horn CarrierKYP · Traditional | Chiron Vision Corp. | 05/25/1983SE |