The following data is part of a premarket notification filed by Vision Pro, L.l.c. with the FDA for Lafaci.
| Device ID | K032400 |
| 510k Number | K032400 |
| Device Name: | LAFACI |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | VISION PRO, L.L.C. 1050 CONNECTICUT AVENUE, NW Washington, DC 20036 |
| Contact | Wayne H Matelski |
| Correspondent | Wayne H Matelski VISION PRO, L.L.C. 1050 CONNECTICUT AVENUE, NW Washington, DC 20036 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-04 |
| Decision Date | 2004-05-07 |
| Summary: | summary |