The following data is part of a premarket notification filed by Hillusa, Inc. with the FDA for Hm-lamp Ii.
| Device ID | K100234 |
| 510k Number | K100234 |
| Device Name: | HM-LAMP II |
| Classification | Lamp, Surgical |
| Applicant | HILLUSA, INC. 7215 N.W. 46TH ST. Miami, FL 33166 |
| Contact | Maria Guma |
| Correspondent | Maria Guma HILLUSA, INC. 7215 N.W. 46TH ST. Miami, FL 33166 |
| Product Code | FTD |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-26 |
| Decision Date | 2010-07-08 |
| Summary: | summary |