The following data is part of a premarket notification filed by Nsp Tech Pte Ltd with the FDA for Bevel Up Holder.
Device ID | K193074 |
510k Number | K193074 |
Device Name: | Bevel Up Holder |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | NSP Tech Pte Ltd 10 Admiralty Street, Northlink Building, #02-06 Singapore, SG 757695 |
Contact | Hc Tan |
Correspondent | Hc Tan NSP Tech Pte Ltd 10 Admiralty Street, Northlink Building, #02-06 Singapore, SG 757695 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-11-04 |
Decision Date | 2020-04-21 |