The following data is part of a premarket notification filed by Salient Surgical Technologies, Inc. with the FDA for Aquamantys Sbs 5.0 Sheated Biopolar Sealer.
| Device ID | K111732 |
| 510k Number | K111732 |
| Device Name: | AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SALIENT SURGICAL TECHNOLOGIES, INC. 180 INTERNATIONAL DRIVE Portsmouth, NH 03801 |
| Contact | Martin J Leighton |
| Correspondent | Martin J Leighton SALIENT SURGICAL TECHNOLOGIES, INC. 180 INTERNATIONAL DRIVE Portsmouth, NH 03801 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-20 |
| Decision Date | 2011-12-05 |
| Summary: | summary |