The following data is part of a premarket notification filed by Srs Intl. with the FDA for Transcom Colon Hydrotherapy Model Hc-2000.
| Device ID | K970482 |
| 510k Number | K970482 |
| Device Name: | TRANSCOM COLON HYDROTHERAPY MODEL HC-2000 |
| Classification | Colonic Irrigation System |
| Applicant | SRS INTL. 1625 K ST. NW SUITE 1000 Washington, DC 20006 -1604 |
| Contact | Michael G Farrow, Ph.d. |
| Correspondent | Michael G Farrow, Ph.d. SRS INTL. 1625 K ST. NW SUITE 1000 Washington, DC 20006 -1604 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-10 |
| Decision Date | 1997-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B482HC2000C1 | K970482 | 000 |