The following data is part of a premarket notification filed by Meadox Medicals, Div. Boston Scientific Corp. with the FDA for Tape, Vascular, 1/4 Dacron.
Device ID | K760087 |
510k Number | K760087 |
Device Name: | TAPE, VASCULAR, 1/4 DACRON |
Classification | Instruments, Surgical, Cardiovascular |
Applicant | MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DWS |
CFR Regulation Number | 870.4500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-06-21 |
Decision Date | 1976-07-20 |