The following data is part of a premarket notification filed by Pro.duct Health, Inc. with the FDA for Pro.duct Catheter, Model Cth03.
| Device ID | K000135 |
| 510k Number | K000135 |
| Device Name: | PRO.DUCT CATHETER, MODEL CTH03 |
| Classification | Instrument, Biopsy |
| Applicant | PRO.DUCT HEALTH, INC. 1010 HAMILTON CT. Menlo Park, CA 94025 |
| Contact | Angela B Soito |
| Correspondent | Angela B Soito PRO.DUCT HEALTH, INC. 1010 HAMILTON CT. Menlo Park, CA 94025 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-18 |
| Decision Date | 2000-04-10 |