The following data is part of a premarket notification filed by Primary Care Solutions, Inc. with the FDA for Primary Care Solutions, Inc., Sterile Water And Saline For Irrigation.
| Device ID | K082330 |
| 510k Number | K082330 |
| Device Name: | PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION |
| Classification | Dressing, Wound, Drug |
| Applicant | PRIMARY CARE SOLUTIONS, INC. 40420 FREE FALL AVE. Zephyrhills, FL 33542 |
| Contact | Ron Maddix |
| Correspondent | Ron Maddix PRIMARY CARE SOLUTIONS, INC. 40420 FREE FALL AVE. Zephyrhills, FL 33542 |
| Product Code | FRO |
| Subsequent Product Code | FQH |
| Subsequent Product Code | JOL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-08-14 |
| Decision Date | 2008-10-09 |
| Summary: | summary |