The following data is part of a premarket notification filed by Voss Medical Products with the FDA for Voss Graft Marker.
| Device ID | K895369 |
| 510k Number | K895369 |
| Device Name: | VOSS GRAFT MARKER |
| Classification | Marker, Ostia, Aorto-saphenous Vein |
| Applicant | VOSS MEDICAL PRODUCTS 4227 CENTERGATE San Antonio, TX 78217 |
| Contact | Steve Holloway |
| Correspondent | Steve Holloway VOSS MEDICAL PRODUCTS 4227 CENTERGATE San Antonio, TX 78217 |
| Product Code | KPK |
| CFR Regulation Number | 878.4650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-29 |
| Decision Date | 1989-09-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811304020072 | K895369 | 000 |
| 00811304020041 | K895369 | 000 |