The following data is part of a premarket notification filed by Medical Engineering Corp. with the FDA for Surgitek (r) Uroflow System.
| Device ID | K883274 |
| 510k Number | K883274 |
| Device Name: | SURGITEK (R) UROFLOW SYSTEM |
| Classification | Device, Urine Flow Rate Measuring, Non-electrical, Disposable |
| Applicant | MEDICAL ENGINEERING CORP. 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | Betty A Lock |
| Correspondent | Betty A Lock MEDICAL ENGINEERING CORP. 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Product Code | FFG |
| CFR Regulation Number | 876.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-03 |
| Decision Date | 1989-02-08 |