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 |