510(k) K973023
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 1997
- Date Received
- August 14, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pack, Hot Or Cold, Water Circulating
- Device Class
- Class II
- Regulation Number
- 890.5720
- Review Panel
- PM
- Submission Type