The following data is part of a premarket notification filed by Midwest Marketing Service with the FDA for Alpha Tan 1000 And Alpha Tan 1200.
Device ID | K861570 |
510k Number | K861570 |
Device Name: | ALPHA TAN 1000 AND ALPHA TAN 1200 |
Classification | Light, Ultraviolet, Dermatological |
Applicant | MIDWEST MARKETING SERVICE 109 E. MAIN ST. Klemme, IA 50449 |
Contact | Noel Katter |
Correspondent | Noel Katter MIDWEST MARKETING SERVICE 109 E. MAIN ST. Klemme, IA 50449 |
Product Code | FTC |
CFR Regulation Number | 878.4630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-28 |
Decision Date | 1986-05-13 |