The following data is part of a premarket notification filed by Asset Medikal Tasarim As. with the FDA for Neutrart.
Device ID | K221481 |
510k Number | K221481 |
Device Name: | NeutrArt |
Classification | Set, Administration, Intravascular |
Applicant | Asset Medikal Tasarim AS. Ikitelli OSB Mahallesi, 17. Cadde, No: 17, Basaksehir Istanbul, TR 34490 |
Contact | Ebru Sirali |
Correspondent | Raymond Kelly Licensale Inc 3422 Leonardo Lane New Smyrna Beach, FL 32168 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-05-23 |
Decision Date | 2022-09-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NEUTRART 98094162 not registered Live/Pending |
Asset Medical International, Inc. 2023-07-20 |
NEUTRART 79310867 not registered Live/Pending |
ASSET MEDIKAL TASARIM SANAYI VE TICARETANONIM SIRKETI 2021-01-26 |