The following data is part of a premarket notification filed by First Medical Infection Control Associates, Inc. with the FDA for Hilux Ledmax 3.
| Device ID | K040956 |
| 510k Number | K040956 |
| Device Name: | HILUX LEDMAX 3 |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | FIRST MEDICAL INFECTION CONTROL ASSOCIATES, INC. 3704-C BOREN DR. Greensboro, NC 27407 |
| Contact | David Small |
| Correspondent | David Small FIRST MEDICAL INFECTION CONTROL ASSOCIATES, INC. 3704-C BOREN DR. Greensboro, NC 27407 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-13 |
| Decision Date | 2004-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D822LB008 | K040956 | 000 |
| D822LB002 | K040956 | 000 |
| D822LB002BK1 | K040956 | 000 |
| D822LB002BL1 | K040956 | 000 |
| D822LB002GR1 | K040956 | 000 |
| D822LB002PR1 | K040956 | 000 |
| D822LB004 | K040956 | 000 |
| D822LB005 | K040956 | 000 |
| D822LB006 | K040956 | 000 |
| D822LB001 | K040956 | 000 |