The following data is part of a premarket notification filed by Neward Enterprises, Inc. with the FDA for Mityvac(r) Saftisoft Obstetrical Vacuum Deliv Kit.
| Device ID | K913324 |
| 510k Number | K913324 |
| Device Name: | MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT |
| Classification | Extractor, Vacuum, Fetal |
| 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 | HDB |
| CFR Regulation Number | 884.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-25 |
| Decision Date | 1992-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30888937003070 | K913324 | 000 |