510(k) K970726
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 18, 1998
- Date Received
- February 28, 1997
- 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