The following data is part of a premarket notification filed by Meadox Medicals, Div. Boston Scientific Corp. with the FDA for Meadox Medicals Inc. Graft Sizer.
| Device ID | K854431 |
| 510k Number | K854431 |
| Device Name: | MEADOX MEDICALS INC. GRAFT SIZER |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland, NJ 07436 |
| Contact | Scott Mindrebo |
| Correspondent | Scott Mindrebo MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 112 BAUER DR. Oakland, NJ 07436 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-05 |
| Decision Date | 1986-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00384401513049 | K854431 | 000 |
| 00384401513032 | K854431 | 000 |