The following data is part of a premarket notification filed by Neward Enterprises, Inc. with the FDA for Mityvac Super M Style Vacum Extractor, Disposable.
| Device ID | K943938 |
| 510k Number | K943938 |
| Device Name: | MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE |
| Classification | Extractor, Vacuum, Fetal |
| Applicant | NEWARD ENTERPRISES, INC. 9251 ARCHIBALD AVE. P.O. BOX 725 Rancho Cucamonga, CA 91729 -0725 |
| Contact | Allyson C Carmark |
| Correspondent | Allyson C Carmark NEWARD ENTERPRISES, INC. 9251 ARCHIBALD AVE. P.O. BOX 725 Rancho Cucamonga, CA 91729 -0725 |
| Product Code | HDB |
| CFR Regulation Number | 884.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-12 |
| Decision Date | 1995-05-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30888937003056 | K943938 | 000 |