The following data is part of a premarket notification filed by Suncoast Medical Manufacturers, Inc. with the FDA for Sun-lite White Spot.
| Device ID | K841588 |
| 510k Number | K841588 |
| Device Name: | SUN-LITE WHITE SPOT |
| Classification | Light, Examination, Medical, Battery Powered |
| Applicant | SUNCOAST MEDICAL MANUFACTURERS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KYT |
| CFR Regulation Number | 880.6350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-18 |
| Decision Date | 1984-05-22 |