The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for E-z-em Vacuum Aspiration Syringe.
| Device ID | K895012 |
| 510k Number | K895012 |
| Device Name: | E-Z-EM VACUUM ASPIRATION SYRINGE |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Contact | Zwarun, Phd |
| Correspondent | Zwarun, Phd E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-08 |
| Decision Date | 1989-12-27 |