510(k) K003454
Clearance Details
- Decision
- ST ()
- Decision Date
- January 18, 2001
- Date Received
- November 7, 2000
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pacemaker Lead Adaptor
- Device Class
- Class II
- Regulation Number
- 870.3620
- Review Panel
- CV
- Submission Type