The following data is part of a premarket notification filed by Medovations, Inc. with the FDA for Stomach Evaculator - Ewald Style.
| Device ID | K864963 |
| 510k Number | K864963 |
| Device Name: | STOMACH EVACULATOR - EWALD STYLE |
| Classification | Surgical Instruments, G-u, Manual (and Accessories) |
| Applicant | MEDOVATIONS, INC. 102 EAST KEEFE AVE. Milwaukee, WI 53212 |
| Contact | Larry R Pierce |
| Correspondent | Larry R Pierce MEDOVATIONS, INC. 102 EAST KEEFE AVE. Milwaukee, WI 53212 |
| Product Code | KOA |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-22 |
| Decision Date | 1987-10-14 |