Table 3:
Distribution of THR Devices Approved by 510k Process Between 1976-1995
Number of Approvals Held by Manufacturer
Number of Approved Devices
Number of Manufacturers
0 < 10
174 (25%)
52 (70%)
10 to 19
169 (24%)
13 (18%)
≥ 20
358 (51%)
9 (12%)
Total
701
74