||Liquid medication dispenser.|
||A device used to cut or crush medication to aid in consumption.The device is intended to only be used with medications that are labeled as acceptable for crushing or cutting.
||The device is aluminum/stainless steel with a handle, linkage arm, and anvil that are connected to pivot points by steel pins.
||Cutting and/or crushing.
|Regulation Medical Specialty
|| General Hospital
Office of Device Evaluation
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices
General Hospital Devices Branch (GHDB)
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
| Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.|
|If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. |
|Third Party Review
||Not Third Party Eligible