The following data is part of a premarket notification filed by Vitalmetrics, Inc. with the FDA for Vital-vue Illumination, Suction And Irrigation.
| Device ID | K882956 |
| 510k Number | K882956 |
| Device Name: | VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATION |
| Classification | Illuminator, Fiberoptic, Surgical Field |
| Applicant | VITALMETRICS, INC. 1150 17TH STREET, N.W. SUITE 1000 Washington, DC 20036 |
| Contact | John B Dubeck |
| Correspondent | John B Dubeck VITALMETRICS, INC. 1150 17TH STREET, N.W. SUITE 1000 Washington, DC 20036 |
| Product Code | HBI |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-13 |
| Decision Date | 1988-08-03 |