510(k) K974406
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 1998
- Date Received
- November 21, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Template
- Device Class
- Class I
- Regulation Number
- 888.4800
- Review Panel
- OR
- Submission Type