The following data is part of a premarket notification filed by U. S. Surgical Corp. with the FDA for Auto Suture Dispos., Eea Surg. Stapler.
| Device ID | K802611 |
| 510k Number | K802611 |
| Device Name: | AUTO SUTURE DISPOS., EEA SURG. STAPLER |
| Classification | Stapler, Surgical |
| Applicant | U. S. SURGICAL CORP. 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 | 1980-10-21 |
| Decision Date | 1980-11-12 |