U.S. Requirements. To market medical products, the Food and Drug Administration (FDA) must determine that a medical device is substantially equivalent to similar marketed medical devices. The Bovie Regulatory department intends to use the dissecting sealer device manufactured by TissueLink as a predicate device.
Appears in 4 contracts
Samples: Termination, Purchase and License Agreement (Bovie Medical Corp), Distribution Agreement (Bovie Medical Corp), Purchase and License Agreement (Bovie Medical Corp)