The following data is part of a premarket notification filed by Medical Engineering Corp. with the FDA for Surgitek Disposable Flo-rester.
| Device ID | K781336 |
| 510k Number | K781336 |
| Device Name: | SURGITEK DISPOSABLE FLO-RESTER |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | MEDICAL ENGINEERING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-03 |
| Decision Date | 1978-10-10 |