The following data is part of a premarket notification filed by Apollo Corp. with the FDA for Remedy Model 2z12.
Device ID | K012029 |
510k Number | K012029 |
Device Name: | REMEDY MODEL 2Z12 |
Classification | Purifier, Water, Ultraviolet, Medical |
Applicant | APOLLO CORP. 450 MAIN ST. Somerset, WI 54025 |
Contact | Adrian Sween |
Correspondent | Adrian Sween APOLLO CORP. 450 MAIN ST. Somerset, WI 54025 |
Product Code | KMG |
CFR Regulation Number | 880.6710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-06-28 |
Decision Date | 2001-12-31 |
Summary: | summary |