The following data is part of a premarket notification filed by Tissuelink Medical, Inc. with the FDA for Modification To Tissuelink Monopolar Floating Ball.
| Device ID | K010662 |
| 510k Number | K010662 |
| Device Name: | MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | TISSUELINK MEDICAL, INC. ONE WASHINGTON CENTER SUITE 400 Dover, NH |
| Contact | Roberta Thompson |
| Correspondent | Roberta Thompson TISSUELINK MEDICAL, INC. ONE WASHINGTON CENTER SUITE 400 Dover, NH |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-01 |
| Decision Date | 2001-04-27 |