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 |