The following data is part of a premarket notification filed by Health Tronics Surgical Services, Inc. with the FDA for Twintrode Elc 134 Electrode.
| Device ID | K012785 |
| 510k Number | K012785 |
| Device Name: | TWINTRODE ELC 134 ELECTRODE |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | HEALTH TRONICS SURGICAL SERVICES, INC. 1841 WEST OAK PARKWAY, SUITE A Marietta, GA 30062 |
| Contact | Peter Weiman |
| Correspondent | Peter Weiman HEALTH TRONICS SURGICAL SERVICES, INC. 1841 WEST OAK PARKWAY, SUITE A Marietta, GA 30062 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-20 |
| Decision Date | 2001-11-16 |
| Summary: | summary |