510(k) K852236
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 1985
- Date Received
- May 22, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Materials, Repair Or Replacement, Pacemaker
- Device Class
- Class III
- Regulation Number
- 870.3710
- Review Panel
- CV
- Submission Type