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 |