The following data is part of a premarket notification filed by Surgitek Medical Engineering Corp. with the FDA for Surgitek(r) Turp Monitor.
| Device ID | K903127 |
| 510k Number | K903127 |
| Device Name: | SURGITEK(R) TURP MONITOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SURGITEK MEDICAL ENGINEERING CORP. 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | Steve Aperavich |
| Correspondent | Steve Aperavich SURGITEK MEDICAL ENGINEERING CORP. 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-16 |
| Decision Date | 1990-10-09 |