The following data is part of a premarket notification filed by Surgical Innovations Corp. with the FDA for Surgical Innovations Disposable Endoscopic Hernia Surgical Stapler Surgical Innovations Resuable Surgical Stapler Handle.
Device ID | K944292 |
510k Number | K944292 |
Device Name: | SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL INNOVATIONS RESUABLE SURGICAL STAPLER HANDLE |
Classification | Endoscopic Tissue Approximation Device |
Applicant | SURGICAL INNOVATIONS CORP. 6 PHEASANT LN. Claremont, NH 03743 |
Contact | Michele Motsiff |
Correspondent | Michele Motsiff SURGICAL INNOVATIONS CORP. 6 PHEASANT LN. Claremont, NH 03743 |
Product Code | OCW |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-02 |
Decision Date | 1994-11-15 |