The following data is part of a premarket notification filed by Primary Care Solutions, Inc. with the FDA for Primary Care Solutions Sterile Water Device Irrigation.
| Device ID | K000265 |
| 510k Number | K000265 |
| Device Name: | PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION |
| Classification | Catheter And Tip, Suction |
| Applicant | PRIMARY CARE SOLUTIONS, INC. 339 STONETOWN RD. Ringwood, NJ 07456 |
| Contact | Norman Ruedt |
| Correspondent | Norman Ruedt PRIMARY CARE SOLUTIONS, INC. 339 STONETOWN RD. Ringwood, NJ 07456 |
| Product Code | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-28 |
| Decision Date | 2001-07-12 |