The following data is part of a premarket notification filed by Neward Enterprises, Inc. with the FDA for Mityvac Directional Vacuum Extractor, Disposable.
| Device ID | K960549 |
| 510k Number | K960549 |
| Device Name: | MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE |
| Classification | Extractor, Vacuum, Fetal |
| Applicant | NEWARD ENTERPRISES, INC. P.O. BOX 725 Cucamonga, CA 91730 |
| Contact | Allyson Carmack |
| Correspondent | Allyson Carmack NEWARD ENTERPRISES, INC. P.O. BOX 725 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 | 1996-02-08 |
| Decision Date | 1996-08-29 |