The following data is part of a premarket notification filed by Applied Medical Research with the FDA for Model 902 Stand.
Device ID | K780759 |
510k Number | K780759 |
Device Name: | MODEL 902 STAND |
Classification | Tray, Surgical, Needle |
Applicant | APPLIED MEDICAL RESEARCH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FSH |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-05-08 |
Decision Date | 1978-05-19 |