The following data is part of a premarket notification filed by Shaw Sun Systems with the FDA for Shaw Sun Systems 1000, 2000 & 3200.
| Device ID | K854515 |
| 510k Number | K854515 |
| Device Name: | SHAW SUN SYSTEMS 1000, 2000 & 3200 |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | SHAW SUN SYSTEMS RT. 2 BOX 216 Brookline, MO 65619 |
| Contact | Donald A Shaw |
| Correspondent | Donald A Shaw SHAW SUN SYSTEMS RT. 2 BOX 216 Brookline, MO 65619 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-12 |
| Decision Date | 1985-11-25 |