Primary Care Solutions, Inc., Sterile Water and Saline for Irrigation
FDA 510(k) K082330 · Primary Care Solutions, Inc.
510(k) numberK082330
Submission
- Device name
- Primary Care Solutions, Inc., Sterile Water and Saline for Irrigation
- Applicant
- Primary Care Solutions, Inc.
Zephyrhills, FL, US - Received
- August 14, 2008
- Decision date
- October 9, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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| K254191 | IWD-GelFRO · Traditional | InnovaCorium, Inc. | 04/07/2026SE |
| K252023 | MiraChlor Antimicrobial Wound SolutionFRO · Traditional | Letus Corporation | 03/25/2026SE |
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More from Solventum Germany GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K030813 | Primary Care Solutions Prefilled 10CC and Prefilled 30CC Inflation Syringes with Sterile…EZL · Traditional | 05/30/2003SE |
| K000266 | Primary Care Solutions Sterile SALINE-0.9% Sodium Chloride for Device IrrigationJOL · Traditional | 07/12/2001SE |
| K000265 | Primary Care Solutions Sterile Water Device IrrigationJOL · Traditional | 07/12/2001SE |
Questions and answers
When was Primary Care Solutions, Inc., Sterile Water and Saline for Irrigation cleared by the FDA?
Primary Care Solutions, Inc., Sterile Water and Saline for Irrigation (K082330) received a 510(k) decision of Substantially Equivalent on October 9, 2008, 56 days after the submission was received.
What is the product code of K082330?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.