3 ms·
Clarification: upon further digging, it turns out that all devices >= class 2 in production before 1976 were granted 510(k) with the intention of transferring c
by Thriptic 9y ago
Clarification: upon further digging, it turns out that all devices >= class 2 in production before 1976 were granted 510(k) with the intention of transferring class 3 devices to pma once regulations were developed for them. Most of these devices were transferred by the time I entered the space and make up a small percentage of the total class 3 devices which is why I was not familiar with this. Ignore that part of my previous statement.