510(k) K880898
K880898 is an FDA 510(k) premarket notification submitted by Tpl-Cordis, Inc. for the device "MULTICOR AND PACEMAKERS". The FDA issued a decision of Substantially Equivalent on May 6, 1988. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Tpl-Cordis, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 1988
- Date Received
- February 26, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implantable Pacemaker Pulse-Generator
- Device Class
- Class III
- Regulation Number
- 870.3610
- Review Panel
- CV
- Submission Type