The following data is part of a premarket notification filed by Vision Medical, Inc. with the FDA for Drolite(tm) Light Source.
| Device ID | K913273 |
| 510k Number | K913273 |
| Device Name: | DROLITE(TM) LIGHT SOURCE |
| Classification | Transilluminator, Ac-powered |
| Applicant | VISION MEDICAL, INC. 820 OPTIMO AVE. Fremont, CA 94539 |
| Contact | Johnny L Yee |
| Correspondent | Johnny L Yee VISION MEDICAL, INC. 820 OPTIMO AVE. Fremont, CA 94539 |
| Product Code | HJM |
| CFR Regulation Number | 886.1945 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-23 |
| Decision Date | 1991-12-04 |