The following data is part of a premarket notification filed by Neward Enterprises, Inc. with the FDA for Mityvac Dispos-a-plate Disposable Leg Plate.
| Device ID | K925572 |
| 510k Number | K925572 |
| Device Name: | MITYVAC DISPOS-A-PLATE DISPOSABLE LEG PLATE |
| Classification | System, Monitoring, Perinatal |
| Applicant | NEWARD ENTERPRISES, INC. P.O. BOX 725 9251 ARCHIBALD AVENUE Cucamonga, CA 91730 |
| Contact | John T Murray |
| Correspondent | John T Murray NEWARD ENTERPRISES, INC. P.O. BOX 725 9251 ARCHIBALD AVENUE Cucamonga, CA 91730 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-03 |
| Decision Date | 1993-10-08 |