The following data is part of a premarket notification filed by Vlv Associates, Inc. with the FDA for Pro-lok (tm) Extension Sets.
| Device ID | K904217 |
| 510k Number | K904217 |
| Device Name: | PRO-LOK (TM) EXTENSION SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | VLV ASSOCIATES, INC. 30 RIDGEDALE AVE. East Hanover, NJ 07936 |
| Contact | Vincent Vaillancourt |
| Correspondent | Vincent Vaillancourt VLV ASSOCIATES, INC. 30 RIDGEDALE AVE. East Hanover, NJ 07936 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-12 |
| Decision Date | 1990-10-03 |