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 3 contracts
Samples: Termination, Purchase and License Agreement (Bovie Medical Corp), Termination, Purchase and License Agreement (Bovie Medical Corp), Distribution Agreement (Bovie Medical Corp)
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.
3.3.1.1 Classification
Appears in 2 contracts
Samples: Termination, Purchase and License Agreement (Bovie Medical Corp), Distribution Agreement (Bovie Medical Corp)
