The following data is part of a premarket notification filed by Angiolaz, Inc. with the FDA for Headlamp Hl2000..
| Device ID | K994362 |
| 510k Number | K994362 |
| Device Name: | HEADLAMP HL2000. |
| Classification | Light, Headband, Surgical |
| Applicant | ANGIOLAZ, INC. P.O. BOX 556 INDUSTRIAL PARK Bellows Falls, VT 05101 |
| Contact | Robert Allman |
| Correspondent | Robert Allman ANGIOLAZ, INC. P.O. BOX 556 INDUSTRIAL PARK Bellows Falls, VT 05101 |
| Product Code | FSR |
| CFR Regulation Number | 886.4335 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-27 |
| Decision Date | 2000-05-11 |