The following data is part of a premarket notification filed by Sage Products, Inc. with the FDA for Blood Needle Holder.
Device ID | K873569 |
510k Number | K873569 |
Device Name: | BLOOD NEEDLE HOLDER |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | SAGE PRODUCTS, INC. 680 INDUSTRIAL DR. Cary, IL 60013 |
Contact | Paul H Hanifl |
Correspondent | Paul H Hanifl SAGE PRODUCTS, INC. 680 INDUSTRIAL DR. Cary, IL 60013 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-02 |
Decision Date | 1987-11-03 |