The following data is part of a premarket notification filed by Waters Assoc., Inc. with the FDA for Pan-am Myelogram Tray.
Device ID | K801431 |
510k Number | K801431 |
Device Name: | PAN-AM MYELOGRAM TRAY |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | WATERS ASSOC., 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 | 1980-06-18 |
Decision Date | 1980-08-12 |