The following data is part of a premarket notification filed by Vlv Associates, Inc. with the FDA for Vlv Solodraw(tm) Dual Chamber Piston Syringe.
| Device ID | K945592 |
| 510k Number | K945592 |
| Device Name: | VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGE |
| Classification | Syringe, Piston |
| Applicant | VLV ASSOCIATES, INC. 30-C RIDGEDALE AVE. East Hanover, NJ 07936 |
| Contact | Vincent L Vailancourt |
| Correspondent | Vincent L Vailancourt VLV ASSOCIATES, INC. 30-C RIDGEDALE AVE. East Hanover, NJ 07936 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1995-07-14 |