The following data is part of a premarket notification filed by Terumo America, Inc. with the FDA for Av Fistula Needle Set.
Device ID | K771206 |
510k Number | K771206 |
Device Name: | AV FISTULA NEEDLE SET |
Classification | Needle, Fistula |
Applicant | TERUMO AMERICA, INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | FIE |
CFR Regulation Number | 876.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-07-05 |
Decision Date | 1977-07-15 |