The following data is part of a premarket notification filed by Arent Fox with the FDA for Safety Plus.
Device ID | K945843 |
510k Number | K945843 |
Device Name: | SAFETY PLUS |
Classification | Syringe, Cartridge |
Applicant | ARENT FOX 1050 CONNECTICUT AVE. N.W. Washington, DC 20036 |
Contact | Peter S Reichertz |
Correspondent | Peter S Reichertz ARENT FOX 1050 CONNECTICUT AVE. N.W. Washington, DC 20036 |
Product Code | EJI |
CFR Regulation Number | 872.6770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-30 |
Decision Date | 1995-07-11 |