Endo-Spor Plus / Hyprocide
FDA 510(k) K972708 · Cottrell, Ltd.
510(k) numberK972708
Submission
- Device name
- Endo-Spor Plus / Hyprocide
- Applicant
- Cottrell, Ltd.
Englewood, CO, US - Received
- July 21, 1997
- Decision date
- September 13, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MED – Sterilant, Medical Devices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6885
- Specialty
- General Hospital
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Questions and answers
When was Endo-Spor Plus / Hyprocide cleared by the FDA?
Endo-Spor Plus / Hyprocide (K972708) received a 510(k) decision of Substantially Equivalent on September 13, 1999, 784 days after the submission was received.
What is the product code of K972708?
The FDA product code is MED – Sterilant, Medical Devices, a Class II (moderate risk) device regulated under 21 CFR 880.6885.