Class I - Dangerous
The devices were distributed without required FDA premarket clearance or approval.
The devices were distributed without required FDA premarket clearance or approval.
The devices were distributed without required FDA premarket clearance or approval.
The devices were distributed without required FDA premarket clearance or approval.
The devices were distributed without required FDA premarket clearance or approval.
The devices were distributed without required FDA premarket clearance or approval.
The devices were distributed without required FDA premarket clearance or approval.