The following data is part of a premarket notification filed by Vlv Associates, Inc. with the FDA for Promed Biopsy Needle.
| Device ID | K933364 |
| 510k Number | K933364 |
| Device Name: | PROMED BIOPSY NEEDLE |
| Classification | Needle, Biopsy, Cardiovascular |
| Applicant | VLV ASSOCIATES, INC. 30C RIDGEDALE AVE. East Hanover, NJ 07936 |
| Contact | Vincent L Vaillancourt |
| Correspondent | Vincent L Vaillancourt VLV ASSOCIATES, INC. 30C RIDGEDALE AVE. East Hanover, NJ 07936 |
| Product Code | DWO |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-09 |
| Decision Date | 1994-02-15 |