AQUA CLEANSE
Colonic Irrigation System
QUALITY MEDICAL SUPPLY, INC
The following data is part of a premarket notification filed by Quality Medical Supply, Inc with the FDA for Aqua Cleanse.
Pre-market Notification Details
| Device ID | K150381 |
| 510k Number | K150381 |
| Device Name: | AQUA CLEANSE |
| Classification | Colonic Irrigation System |
| Applicant | QUALITY MEDICAL SUPPLY, INC 13174 W. FOXFIRE DRIVE, SUITE B132 Surprise, AZ 85378 |
| Contact | Julie Solomon |
| Correspondent | Julie Solomon QUALITY MEDICAL SUPPLY, INC 13174 W. FOXFIRE DRIVE, SUITE B132 Surprise, AZ 85378 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-18 |
| Decision Date | 2015-09-11 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850014947163 | K150381 | 000 |
Trademark Results [AQUA CLEANSE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AQUA CLEANSE 74251912 1842835 Dead/Cancelled |
SPACE FOCUS, INC. 1992-03-03 |
 AQUA CLEANSE 74149734 not registered Dead/Abandoned |
HOMESTAR PRODUCTS, INC. 1991-03-21 |
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