Device Classification Name |
Monitor, Pressure, Intrauterine
|
510(k) Number |
K885316 |
Device Name |
DISPOSABLE INTRAUTERINE PRESSURE KIT MODEL 13972A |
Applicant |
HEWLETT-PACKARD CO. |
3000 MINUTEMAN RD. |
ANDOVER,
MA
01810 -1085
|
|
Applicant Contact |
VAN DEUSEN |
Correspondent |
HEWLETT-PACKARD CO. |
3000 MINUTEMAN RD. |
ANDOVER,
MA
01810 -1085
|
|
Correspondent Contact |
VAN DEUSEN |
Regulation Number | 884.2700
|
Classification Product Code |
|
Date Received | 12/29/1988 |
Decision Date | 03/23/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|