510(k) K852236
- Device
- Medtronic Model 5867-1a
- Applicant
- MEDTRONIC VASCULAR
- 510(k) number
- K852236
- Product code
- KFJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-07-11
- Date received
- 1985-05-22
- Regulation
- 870.3710
- Classification name
- Materials, Repair Or Replacement, Pacemaker
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 3
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ED W NUMAINVILLE
- Address
- 800 53rd Ave., NE P.O. Box 1250 Minneapolis MN US 55440 55440
Source Documents#
510(k) summary PDF not indicated by FDA