The following data is part of a premarket notification filed by Telemed Systems, Inc. with the FDA for 5.0 French X 200cm X 35mm Tip Taper-20mm Cutting Wire, 5.0 French X 200cm X 35mm Tip Taper-30mm Cutting Wire, 5.0 French.
| Device ID | K992402 |
| 510k Number | K992402 |
| Device Name: | 5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | TELEMED SYSTEMS, INC. 19 BRIGHAM ST., UNIT 1 Marlborough, MA 01752 |
| Contact | John A Chaves |
| Correspondent | John A Chaves TELEMED SYSTEMS, INC. 19 BRIGHAM ST., UNIT 1 Marlborough, MA 01752 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-19 |
| Decision Date | 1999-12-22 |