The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for E-z-em(r) Lufkin Biopsy Needles.
| Device ID | K882601 |
| 510k Number | K882601 |
| Device Name: | E-Z-EM(R) LUFKIN BIOPSY NEEDLES |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Contact | Jack T Berger |
| Correspondent | Jack T Berger E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-24 |
| Decision Date | 1988-07-25 |