The following data is part of a premarket notification filed by Arnold Tuber Industries with the FDA for Aspirating Syringe, Non-aspirating Syringe.
Device ID | K092943 |
510k Number | K092943 |
Device Name: | ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE |
Classification | Syringe, Cartridge |
Applicant | ARNOLD TUBER INDUSTRIES 97 MAIN STREET Hamburg, NY 14075 |
Contact | Michael Tuber |
Correspondent | Michael Tuber ARNOLD TUBER INDUSTRIES 97 MAIN STREET Hamburg, NY 14075 |
Product Code | EJI |
CFR Regulation Number | 872.6770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-09-24 |
Decision Date | 2009-12-11 |
Summary: | summary |