The following data is part of a premarket notification filed by Cooper-hewitt Electric Co. with the FDA for Spertilite Phototherapy Lamp.
| Device ID | K862608 |
| 510k Number | K862608 |
| Device Name: | SPERTILITE PHOTOTHERAPY LAMP |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | COOPER-HEWITT ELECTRIC CO. ARENT,FOX,KINTNER,PLOTKIN,KAHN 1050 CONNECTICUT AVENUE, N. W. Washington, DC 20036 |
| Contact | P. S Reichertz |
| Correspondent | P. S Reichertz COOPER-HEWITT ELECTRIC CO. ARENT,FOX,KINTNER,PLOTKIN,KAHN 1050 CONNECTICUT AVENUE, N. W. Washington, DC 20036 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-08 |
| Decision Date | 1986-08-06 |