Device Classification Name |
cap, cervical
|
510(k) Number |
K861305 |
Device Name |
INTRAUTERINE CATHETER |
Applicant |
RAM DEVELOPMENT |
28 REMEZ ST |
NES-ZIONA 70400 |
ISRAEL,
IL
|
|
Applicant Contact |
ITZIK RABINOVITZ |
Correspondent |
RAM DEVELOPMENT |
28 REMEZ ST |
NES-ZIONA 70400 |
ISRAEL,
IL
|
|
Correspondent Contact |
ITZIK RABINOVITZ |
Regulation Number | 884.5250
|
Classification Product Code |
|
Date Received | 04/07/1986 |
Decision Date | 12/11/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|