The following data is part of a premarket notification filed by Flier's Quality Water Systems Inc with the FDA for Acute Portable Exchange Deionization (pedi) System, Central Pedi System, Back-up Pedi System.
Device ID | K071104 |
510k Number | K071104 |
Device Name: | ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM |
Classification | Subsystem, Water Purification |
Applicant | FLIER'S QUALITY WATER SYSTEMS INC 7425 CLYDE PARK AVENUE SW SUITE A Byron Center, MI 49315 |
Contact | James Flier |
Correspondent | James Flier FLIER'S QUALITY WATER SYSTEMS INC 7425 CLYDE PARK AVENUE SW SUITE A Byron Center, MI 49315 |
Product Code | FIP |
CFR Regulation Number | 876.5665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-04-19 |
Decision Date | 2008-01-14 |
Summary: | summary |