510(k) K960513
K960513 is an FDA 510(k) premarket notification submitted by Minntech Corp. for the device "PERACT 20 LIQUID STERILANT". The FDA issued a decision of Substantially Equivalent on October 1, 1997. 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
- October 1, 1997
- Date Received
- February 5, 1996
- 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