510(k) K032914
K032914 is an FDA 510(k) premarket notification submitted by Raven Biological Laboratories, Inc. for the device "MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS". The FDA issued a decision of Substantially Equivalent on May 25, 2004. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Raven Biological Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 2004
- Date Received
- September 22, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator, Biological Sterilization Process
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type