The following data is part of a premarket notification filed by Anthogyr with the FDA for Eroject, Miniject, Self Aspirating Syringes, Aspirating Syringes, Non Aspirating Syringes.
Device ID | K040671 |
510k Number | K040671 |
Device Name: | EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES |
Classification | Syringe, Cartridge |
Applicant | ANTHOGYR 164 RUE DE TROIS LACS Sallanches, FR 74700 |
Contact | Eric Geneve |
Correspondent | Eric Geneve ANTHOGYR 164 RUE DE TROIS LACS Sallanches, FR 74700 |
Product Code | EJI |
CFR Regulation Number | 872.6770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-03-15 |
Decision Date | 2004-12-14 |
Summary: | summary |