The following data is part of a premarket notification filed by Amsco Co. with the FDA for Sternum Saw Blade.
Device ID | K802838 |
510k Number | K802838 |
Device Name: | STERNUM SAW BLADE |
Classification | Blade, Saw, General & Plastic Surgery, Surgical |
Applicant | AMSCO CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GFA |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-11-12 |
Decision Date | 1980-12-11 |