The following data is part of a premarket notification filed by Aquaciser, Inc. with the FDA for Aquaciser System.
Device ID | K890548 |
510k Number | K890548 |
Device Name: | AQUACISER SYSTEM |
Classification | Bath, Hydro-massage |
Applicant | AQUACISER, INC. 333 WEST WACKER DR. SUITE 1900 Chicago, IL 60606 |
Contact | Thomas J Muldoon |
Correspondent | Thomas J Muldoon AQUACISER, INC. 333 WEST WACKER DR. SUITE 1900 Chicago, IL 60606 |
Product Code | ILJ |
CFR Regulation Number | 890.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-03 |
Decision Date | 1989-02-13 |