510(k) K813518
K813518 is an FDA 510(k) premarket notification submitted by Intermedics, Inc. for the device "IMPLANT AID SPLICING CRIMP & SLEEVE". The FDA issued a decision of Substantially Equivalent on January 12, 1982. The device falls under product code KFJ (Materials, Repair Or Replacement, Pacemaker), a Class III device regulated under 21 CFR 870.3710. Intermedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 1982
- Date Received
- December 16, 1981
- 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