Scotts Tap Water Substitute Concentrate
FDA 510(k) K830515 · Surgipath Medical Industries, Inc.
510(k) numberK830515
Submission
- Device name
- Scotts Tap Water Substitute Concentrate
- Applicant
- Surgipath Medical Industries, Inc.
Mchenry, IL, US - Received
- February 17, 1983
- Decision date
- March 31, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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|---|---|---|---|
| K792709 | Koh Mounting Fluid W/GlycerolKEQ · Traditional | Meridian Diagnostics, Inc. | 01/24/1980SE |
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| K792702 | Vaspar SealantKEQ · Traditional | Meridian Diagnostics, Inc. | 01/24/1980SE |
| K781869 | Dropper, Cepti-Seal Koh SolutionKEQ · Traditional | Marion Laboratories, Inc. | 11/22/1978SE |
| K781868 | Dropper, Cepti-Seal LavtophenolKEQ · Traditional | Marion Laboratories, Inc. | 11/22/1978SE |
| K781388 | F.A. Mounting MediumKEQ · Traditional | Flow Laboratories, Inc. | 08/21/1978SE |
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Questions and answers
When was Scotts Tap Water Substitute Concentrate cleared by the FDA?
Scotts Tap Water Substitute Concentrate (K830515) received a 510(k) decision of Substantially Equivalent on March 31, 1983, 42 days after the submission was received.
What is the product code of K830515?
The FDA product code is KEQ – Media, Mounting, Water Soluble, a Class I (low risk) device regulated under 21 CFR 864.4010.