510(k) K120306
K120306 is an FDA 510(k) premarket notification submitted by Minntech Corp. for the device "RAPICIDE OPA-28". The FDA issued a decision of Substantially Equivalent on September 27, 2012. The device falls under product code MED (Sterilant, Medical Devices), a Class II device regulated under 21 CFR 880.6885. Minntech Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 2012
- Date Received
- February 1, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilant, Medical Devices
- Device Class
- Class II
- Regulation Number
- 880.6885
- Review Panel
- HO
- Submission Type