The following data is part of a premarket notification filed by Aquarius Technologies, Inc. with the FDA for Clean Source I, Model Cs1000.
Device ID | K981144 |
510k Number | K981144 |
Device Name: | CLEAN SOURCE I, MODEL CS1000 |
Classification | Unit, Operative Dental |
Applicant | AQUARIUS TECHNOLOGIES, INC. 1822 SUNSET PL. Longmont, CO 80501 |
Contact | William Jeffers |
Correspondent | William Jeffers AQUARIUS TECHNOLOGIES, INC. 1822 SUNSET PL. Longmont, CO 80501 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-03-30 |
Decision Date | 1998-09-15 |