Siddhartha230
Registered
Hi All,
Can anyone tell me, why some medical devices have the detailed 510(k) summary in the 510(k) search database, but some only have the brief 510(k) statement?
Here are the examples:
1. K153283, VivoSight Dx Topical OCT System, only has the brief 510(k) statement in the database, but
2. K160878, OPTIS Metallic Stent Optimization E.4 SW, has the detailed 510(k) summary in the database,
even though these two devices have the same Regulation Number (892.1560).
Thanks.
Can anyone tell me, why some medical devices have the detailed 510(k) summary in the 510(k) search database, but some only have the brief 510(k) statement?
Here are the examples:
1. K153283, VivoSight Dx Topical OCT System, only has the brief 510(k) statement in the database, but
2. K160878, OPTIS Metallic Stent Optimization E.4 SW, has the detailed 510(k) summary in the database,
even though these two devices have the same Regulation Number (892.1560).
Thanks.