The following data is part of a premarket notification filed by E.m. Adams with the FDA for Sterile Disp. Instrument Trays.
Device ID | K831841 |
510k Number | K831841 |
Device Name: | STERILE DISP. INSTRUMENT TRAYS |
Classification | Kit, Surgical Instrument, Disposable |
Applicant | E.M. ADAMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KDD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-07 |
Decision Date | 1983-12-14 |