510(k) K983068
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2000
- Date Received
- September 2, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Pasteurization, Hot Water
- Device Class
- Class II
- Regulation Number
- 880.6991
- Review Panel
- HO
- Submission Type