The following data is part of a premarket notification filed by Surgical Innovations Corp. with the FDA for Dispos/reusable Surg Skin/stainless Steel Staples.
| Device ID | K934105 |
| 510k Number | K934105 |
| Device Name: | DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES |
| Classification | Stapler, Surgical |
| Applicant | SURGICAL INNOVATIONS CORP. 6 PHEASANT LN. Claremont, NH 03743 |
| Contact | Jack Yazinski |
| Correspondent | Jack Yazinski SURGICAL INNOVATIONS CORP. 6 PHEASANT LN. Claremont, NH 03743 |
| Product Code | GAG |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-23 |
| Decision Date | 1994-03-28 |