The following data is part of a premarket notification filed by Davis & Geck, Inc. with the FDA for Appose Ule Sterile Dispos. Skin Stap.
Device ID | K840177 |
510k Number | K840177 |
Device Name: | APPOSE ULE STERILE DISPOS. SKIN STAP |
Classification | Stapler, Surgical |
Applicant | DAVIS & GECK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GAG |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-17 |
Decision Date | 1984-03-05 |