The following data is part of a premarket notification filed by Neward Enterprises, Inc. with the FDA for Mityvac M Style Vacuum Extractor, Disposable.
| Device ID | K890307 |
| 510k Number | K890307 |
| Device Name: | MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE |
| Classification | Extractor, Vacuum, Fetal |
| Applicant | NEWARD ENTERPRISES, INC. P.O. BOX 725 9251 ARCHIBALD AVENUE Cucamonga, CA 91730 |
| Contact | Allyson C Carmack |
| Correspondent | Allyson C Carmack 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 | 1989-01-23 |
| Decision Date | 1989-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937003134 | K890307 | 000 |
| 20888937003127 | K890307 | 000 |
| 30888937003094 | K890307 | 000 |
| 20888937003066 | K890307 | 000 |
| 30888937003049 | K890307 | 000 |