Device Classification Name |
Extractor, Vacuum, Fetal
|
510(k) Number |
K980212 |
Device Name |
MITYVAC |
Applicant |
PRISM TECHNOLOGIES, INC. |
555 THIRTEENTH STREET, N.W. |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
HOWARD M HOLSTEIN, ESQ. |
Correspondent |
PRISM TECHNOLOGIES, INC. |
555 THIRTEENTH STREET, N.W. |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
HOWARD M HOLSTEIN, ESQ. |
Regulation Number | 884.4340
|
Classification Product Code |
|
Date Received | 01/21/1998 |
Decision Date | 07/09/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|