510(k) K973439
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 1997
- Date Received
- September 10, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tester, Pulp
- Device Class
- Class II
- Regulation Number
- 872.1720
- Review Panel
- DE
- Submission Type