The following data is part of a premarket notification filed by Viox Corp. with the FDA for Duffy Bolus Injector.
| Device ID | K863936 |
| 510k Number | K863936 |
| Device Name: | DUFFY BOLUS INJECTOR |
| Classification | Holder, Syringe, Lead |
| Applicant | VIOX CORP. 6701 SIXTH AVE. SOUTH Seattle, WA 98108 |
| Contact | Thomas W Burnett |
| Correspondent | Thomas W Burnett VIOX CORP. 6701 SIXTH AVE. SOUTH Seattle, WA 98108 |
| Product Code | IWR |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-09 |
| Decision Date | 1987-01-06 |