Device Classification Name |
Extractor, Vacuum, Fetal
|
510(k) Number |
K890307 |
Device Name |
MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE |
Applicant |
NEWARD ENTERPRISES, INC. |
P.O. BOX 725 |
9251 ARCHIBALD AVENUE |
CUCAMONGA,
CA
91730
|
|
Applicant Contact |
ALLYSON C CARMACK |
Correspondent |
NEWARD ENTERPRISES, INC. |
P.O. BOX 725 |
9251 ARCHIBALD AVENUE |
CUCAMONGA,
CA
91730
|
|
Correspondent Contact |
ALLYSON C CARMACK |
Regulation Number | 884.4340
|
Classification Product Code |
|
Date Received | 01/23/1989 |
Decision Date | 03/31/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|