The following data is part of a premarket notification filed by Neward Enterprises, Inc. with the FDA for Mityvac(r) Obstetric Vac Deliv Kit W/univ Vac Release.
| Device ID | K934011 |
| 510k Number | K934011 |
| Device Name: | MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE |
| Classification | Extractor, Vacuum, Fetal |
| Applicant | NEWARD ENTERPRISES, INC. P.O. BOX 725 9251 ARCHIBALD AVENUE Cucamonga, CA 91730 |
| Contact | Madeleine F Nuci |
| Correspondent | Madeleine F Nuci NEWARD ENTERPRISES, INC. P.O. BOX 725 9251 ARCHIBALD AVENUE Cucamonga, CA 91730 |
| Product Code | HDB |
| CFR Regulation Number | 884.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-17 |
| Decision Date | 1994-05-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937003080 | K934011 | 000 |