The following data is part of a premarket notification filed by Salient Surgical Technologies, Inc. with the FDA for Aquamantys 3 Pump Generator, Bipolar Sealer, Bipolar Sealer With Cutting.
| Device ID | K111285 |
| 510k Number | K111285 |
| Device Name: | AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SALIENT SURGICAL TECHNOLOGIES, INC. 180 INTERNATIONAL DRIVE Portsmouth, NH 03801 |
| Contact | Rita M Calnan |
| Correspondent | Rita M Calnan 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 | 2011-05-06 |
| Decision Date | 2011-09-09 |
| Summary: | summary |