510(k) K001915
- Device
- GRAFT MARKER RING
- Applicant
- T. Korossurgical Instruments Corp.
- 510(k) number
- K001915
- Product code
- MAB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-04-27
- Date received
- 2000-06-23
- Regulation
- 870.3450
- Classification name
- Marker, Cardiopulmonary Bypass (Vein Marker)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- TIBOR KOROS
- Address
- 610 Flinn Ave. Moorepark CA US 93021 93021
FDA Registration Numbers#
- 2183319
- 1424263
- 3010041511
- 3011137372
- 1316297
- 2126670
Source Documents#
510(k) summary PDF not indicated by FDA