The following data is part of a premarket notification filed by Tissuelink Medical, Inc. with the FDA for Tissuelink Floating Ball Model 23-201-1.
| Device ID | K032132 |
| 510k Number | K032132 |
| Device Name: | TISSUELINK FLOATING BALL MODEL 23-201-1 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-11 |
| Decision Date | 2003-08-20 |
| Summary: | summary |