The following data is part of a premarket notification filed by Guilin Woodpecker Medical Instrument Co., Ltd with the FDA for Led.l, Led.m, Led.g, Led.b.
| Device ID | K080025 |
| 510k Number | K080025 |
| Device Name: | LED.L, LED.M, LED.G, LED.B |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD 340 SHADY GROVE ROAD Flintville, TN 37335 |
| Contact | Charlie Mack |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-01-04 |
| Decision Date | 2008-03-19 |