The following data is part of a premarket notification filed by Tissuelink Medical, Inc. with the FDA for Aquamantys Ss4.0 Bipolar Sealer, Model 23-121-1.
| Device ID | K063639 |
| 510k Number | K063639 |
| Device Name: | AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | TISSUELINK MEDICAL, INC. ONE WASHINGTON CENTER SUITE #400 Dover, NH 03820 |
| Contact | Vicki Anastasi |
| Correspondent | Vicki Anastasi TISSUELINK MEDICAL, INC. ONE WASHINGTON CENTER SUITE #400 Dover, NH 03820 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-07 |
| Decision Date | 2007-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169868212 | K063639 | 000 |
| 00643169465961 | K063639 | 000 |
| 00643169078673 | K063639 | 000 |
| 00643169078604 | K063639 | 000 |