The following data is part of a premarket notification filed by Tissuelink Medical, Inc. with the FDA for Tissuelink Aquamantys Malleable Bipolar Sealer With Light.
| Device ID | K073495 |
| 510k Number | K073495 |
| Device Name: | TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | TISSUELINK MEDICAL, INC. ONE WASHINGTON CENTER SUITE #400 Dover, NH 03820 |
| Contact | Som Kovvuri |
| Correspondent | Som Kovvuri TISSUELINK MEDICAL, INC. ONE WASHINGTON CENTER SUITE #400 Dover, NH 03820 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-12 |
| Decision Date | 2008-01-09 |
| Summary: | summary |