Prospore II
FDA 510(k) K971430 · Raven Biological Laboratories, Inc.
510(k) numberK971430
Submission
- Device name
- Prospore II
- Applicant
- Raven Biological Laboratories, Inc.
Omaha, NE, US - Received
- April 17, 1997
- Decision date
- May 22, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRC – Indicator, Biological Sterilization Process
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
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Questions and answers
When was Prospore II cleared by the FDA?
Prospore II (K971430) received a 510(k) decision of Substantially Equivalent on May 22, 1997, 35 days after the submission was received.
What is the product code of K971430?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.