The following data is part of a premarket notification filed by Barosense, Inc with the FDA for Ace Stapler, Model F0031.
| Device ID | K082044 |
| 510k Number | K082044 |
| Device Name: | ACE STAPLER, MODEL F0031 |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | BAROSENSE, INC 3698-C HAVEN AVENUE Redwood City, CA 94063 |
| Contact | Daniel J Balbierz |
| Correspondent | Daniel J Balbierz BAROSENSE, INC 3698-C HAVEN AVENUE Redwood City, CA 94063 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-18 |
| Decision Date | 2010-05-11 |
| Summary: | summary |