The following data is part of a premarket notification filed by R. A. Fischer Co. Corp. with the FDA for Ultraviolet Treatment Lamps Uv-8 & Uv-9.
Device ID | K852534 |
510k Number | K852534 |
Device Name: | ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9 |
Classification | Light, Ultraviolet, Dermatological |
Applicant | R. A. FISCHER CO. CORP. 517 COMMERCIAL ST. Glendale, CA 91203 |
Contact | Van Orden |
Correspondent | Van Orden R. A. FISCHER CO. CORP. 517 COMMERCIAL ST. Glendale, CA 91203 |
Product Code | FTC |
CFR Regulation Number | 878.4630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-14 |
Decision Date | 1985-11-08 |