The following data is part of a premarket notification filed by Wolff System Technology Corp. with the FDA for Perfect Suntanning Bed.
Device ID | K873589 |
510k Number | K873589 |
Device Name: | PERFECT SUNTANNING BED |
Classification | Booth, Sun Tan |
Applicant | WOLFF SYSTEM TECHNOLOGY CORP. 487 WASHINGTON AVE. Carlstadt, NJ 07072 |
Contact | Stephen M Brickley |
Correspondent | Stephen M Brickley WOLFF SYSTEM TECHNOLOGY CORP. 487 WASHINGTON AVE. Carlstadt, NJ 07072 |
Product Code | LEJ |
CFR Regulation Number | 878.4635 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-04 |
Decision Date | 1987-10-29 |