The following data is part of a premarket notification filed by Spring Health Products, Inc. with the FDA for Spring Powerlite 2000.
| Device ID | K992728 |
| 510k Number | K992728 |
| Device Name: | SPRING POWERLITE 2000 |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | SPRING HEALTH PRODUCTS, INC. 705 GENERAL WASHINGTON AVE. #701 Norristown, PA 19403 |
| Contact | Nathaniel H Lieb |
| Correspondent | Nathaniel H Lieb SPRING HEALTH PRODUCTS, INC. 705 GENERAL WASHINGTON AVE. #701 Norristown, PA 19403 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-13 |
| Decision Date | 1999-09-29 |