The following data is part of a premarket notification filed by Intl. Solarium Manufacturer, Inc. with the FDA for I.s.m. Product Family Model R3600c.
| Device ID | K854170 |
| 510k Number | K854170 |
| Device Name: | I.S.M. PRODUCT FAMILY MODEL R3600C |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | INTL. SOLARIUM MANUFACTURER, INC. 7005 TUJUNGA AVE. North Hollywood, CA 91605 |
| Contact | Ernest B Knapp |
| Correspondent | Ernest B Knapp INTL. SOLARIUM MANUFACTURER, INC. 7005 TUJUNGA AVE. North Hollywood, CA 91605 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-15 |
| Decision Date | 1985-11-08 |