The following data is part of a premarket notification filed by Medical Design & Manufacturing Corp. with the FDA for Hypo Suture.
| Device ID | K834138 |
| 510k Number | K834138 |
| Device Name: | HYPO SUTURE |
| Classification | Stapler, Surgical |
| Applicant | MEDICAL DESIGN & MANUFACTURING 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 | 1983-11-30 |
| Decision Date | 1984-01-27 |