Sterile Water
FDA 510(k) K843796 · Paco Pharmaceutical Services, Inc.
510(k) numberK843796
Submission
- Device name
- Sterile Water
- Applicant
- Paco Pharmaceutical Services, Inc.
Princeton, NJ, US - Received
- September 27, 1984
- Decision date
- December 10, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Paco Pharmaceutical Services, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K865111 | Charter Hard Contact Lens Cleaning SolutionHPX · Traditional | 01/20/1987SE |
| K863974 | Charter Laboratories Inc. Lens LubricantHPX · Traditional | 11/10/1986SE |
| K862952 | Charter Wetting Solution for Hard Contact LensesHPX · Traditional | 09/25/1986SE |
| K843797 | Sterile Saline SolutionBSY · Traditional | 01/18/1985SE |
| K761093 | BandageNAD · Traditional | 01/06/1977SE |
Questions and answers
When was Sterile Water cleared by the FDA?
Sterile Water (K843796) received a 510(k) decision of Substantially Equivalent on December 10, 1984, 74 days after the submission was received.