The following data is part of a premarket notification filed by Sentinel Ch. Srl with the FDA for Sentinel Iron Liquid.
Device ID | K051115 |
510k Number | K051115 |
Device Name: | SENTINEL IRON LIQUID |
Classification | Photometric Method, Iron (non-heme) |
Applicant | SENTINEL CH. SRL 5 VIA PRINCIPE EUGENIO Milano, IT 20155 |
Contact | Davide Spada |
Correspondent | Davide Spada SENTINEL CH. SRL 5 VIA PRINCIPE EUGENIO Milano, IT 20155 |
Product Code | JIY |
CFR Regulation Number | 862.1410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-05-02 |
Decision Date | 2005-08-25 |
Summary: | summary |