The following data is part of a premarket notification filed by Viratec Corp. with the FDA for Vir-a-vac Empty.
| Device ID | K882315 |
| 510k Number | K882315 |
| Device Name: | VIR-A-VAC EMPTY |
| Classification | Tubing, Noninvasive |
| Applicant | VIRATEC CORP. 150 MARBLEDALE RD. Tuckahoe, NY 10707 |
| Contact | Allen P Schlein |
| Correspondent | Allen P Schlein VIRATEC CORP. 150 MARBLEDALE RD. Tuckahoe, NY 10707 |
| Product Code | GAZ |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-03 |
| Decision Date | 1988-09-26 |