The following data is part of a premarket notification filed by Wilo Medizintechnik Lothar Wilberg Gmbh with the FDA for Wilo Series Secur, Automatic Trocar Set, Trocar, Conical, Triangular Ground, Safety W/out Lock, Set Of Suction - Irriga0.
| Device ID | K955792 |
| 510k Number | K955792 |
| Device Name: | WILO SERIES SECUR, AUTOMATIC TROCAR SET, TROCAR, CONICAL, TRIANGULAR GROUND, SAFETY W/OUT LOCK, SET OF SUCTION - IRRIGA0 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | WILO MEDIZINTECHNIK LOTHAR WILBERG GMBH 2550 M STREET, N.W. Washington, DC 20037 |
| Contact | Mark Heller |
| Correspondent | Mark Heller WILO MEDIZINTECHNIK LOTHAR WILBERG GMBH 2550 M STREET, N.W. Washington, DC 20037 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-22 |
| Decision Date | 1996-07-26 |