FDA 510(k) Applications for Medical Device:
Colonic Irrigation System
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K000388 | CLEARWATER COLON HYDROTHERAPY, INC. |
4451-A SOUTH PINE AVE. | OCALA | FL | 34480 |
| K942867 | CLEARWATER COLON HYDROTHERAPY, INC. |
3130 THOMAS RD. | CLEARWATER | FL | 34619 |
| K094022 | CLEARWATER PRODUCTS, LLC |
1468 HARWELL AVE. | CROFTON | MD | 21114 |
| K972455 | COLON THERAPEUTICS |
6249 25TH ST. | GROVES | TX | 77619 |
| K973256 | COLON THERAPEUTICS |
209 MAIN AVE. | GROVES | TX | 77619 |
| K180800 | Colonic Plus |
73-925 Hwy 111, Ste. L | Palm Desert | CA | 92260 |
| K152834 | COLONPLUS EQUIPMENTS & SPECULUMS, S.L. |
C/Portuetxe 13, 1 C 20018 | San Sebastian (Guipuzcoa) | ||
| K050992 | CONMED CORP. |
525 FRENCH RD. | UTICA | NY | 13502 |
| K980868 | GENTLE COLONICS, INC. |
3722 AVENUE SAUSALITO | IRVINE | CA | 92606-1849 |
| K002102 | GENTLE COLONICS, INC. |
3722 AVENUE SAUSALITO | IRVINE | CA | 92606-1849 |
| K201861 | Gnali Bocia S.R.L. |
Via Brescia, 41/M-N | Lumezzane | 25065 | |
| K003720 | LIFESTREAM PURFICATION SYSTEMS, LLC. |
6401 MEADOWS WEST DR. | FORT WORTH | TX | 76132 |
| K000031 | PRIME PACIFIC HEALTH INNOVATIONS CORPORATION |
145 RIVERSIDE DR. | NORTH VANCOUVER | V7H 1T6 | |
| K050112 | PRIME PACIFIC HEALTH INNOVATIONS CORPORATION |
8-145 RIVERSIDE DR. | NORTH VANCOUVER, BC | V7H 1T6 | |
| K150381 | QUALITY MEDICAL SUPPLY, INC |
13174 W. FOXFIRE DRIVE, SUITE B132 | SURPRISE | AZ | 85378 |
| K970482 | SRS INTL. |
1625 K ST. NW | WASHINGTON | DC | 20006-1604 |
| K071057 | TILLER MIND BODY, INC. |
42 EAST WHISTERS BEND CIRCLE | THE WOODLANDS | TX | 77384 |
| K962259 | TILLER MIND BODY, INC. |
2204 N.W. LOOP 410 #2C | SAN ANTONIO | TX | 78230 |
| K131852 | TRANSCENDENCIAS COMERCIALES SL TRANSCOM |
C/ZUBIBERRI 31- PLANTA BAJA LOCAL 1 | SAN SEBASTIAN, GUIPUZCOA | 20018 | |
| K051344 | ULTIMATE CONCEPTS, INC. |
3722 AVE. SAUSALITO | IRVINE | CA | 92606 |
| K033149 | ULTIMATE CONCEPTS, INC. |
3722 AVE. SAUSALITO | IRVINE | CA | 92606 |
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