The following data is part of a premarket notification filed by Medical Engineering Corp. with the FDA for Surgitek Co2 Delivery System.
| Device ID | K881736 |
| 510k Number | K881736 |
| Device Name: | SURGITEK CO2 DELIVERY SYSTEM |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | MEDICAL ENGINEERING CORP. 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | Waxberg |
| Correspondent | Waxberg MEDICAL ENGINEERING CORP. 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-22 |
| Decision Date | 1988-08-11 |