The following data is part of a premarket notification filed by Terumo America, Inc. with the FDA for Disp. Hypodermic Needle.
Device ID | K771203 |
510k Number | K771203 |
Device Name: | DISP. HYPODERMIC NEEDLE |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | TERUMO AMERICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-07-05 |
Decision Date | 1977-07-14 |