The following data is part of a premarket notification filed by Leisegang Medical, Inc. with the FDA for Lm-150ht Light Source.
| Device ID | K911212 |
| 510k Number | K911212 |
| Device Name: | LM-150HT LIGHT SOURCE |
| Classification | Polymer, Natural-absorbable Gelatin Material |
| Applicant | LEISEGANG MEDICAL, INC. 6401 CONGRESS AVE. Boca Raton, FL 33487 -2883 |
| Contact | Douglas Dwart |
| Correspondent | Douglas Dwart LEISEGANG MEDICAL, INC. 6401 CONGRESS AVE. Boca Raton, FL 33487 -2883 |
| Product Code | ESI |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-19 |
| Decision Date | 1991-05-23 |