The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for All-vue Ultra-lite Thin Wall Syringe Shield.
| Device ID | K934549 |
| 510k Number | K934549 |
| Device Name: | ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD |
| Classification | Holder, Syringe, Lead |
| Applicant | VICTOREEN, INC. 6000 COCHRAN RD. Cleveland, OH 44130 -3304 |
| Contact | Christine L Jess |
| Correspondent | Christine L Jess VICTOREEN, INC. 6000 COCHRAN RD. Cleveland, OH 44130 -3304 |
| Product Code | IWR |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-22 |
| Decision Date | 1994-02-19 |