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 |