Device Classification Name |
Catheter, Assisted Reproduction
|
510(k) Number |
K000656 |
Device Name |
EMBRYON GIFT TRANSFER CATHETERS/SETS |
Applicant |
ROCKET MEDICAL PLC |
WARE INDUSTRIAL ESTATE |
WASHINGTON, TYNE & WEAR,
GB
NE37 1NE
|
|
Applicant Contact |
LES TODD |
Correspondent |
ROCKET MEDICAL PLC |
WARE INDUSTRIAL ESTATE |
WASHINGTON, TYNE & WEAR,
GB
NE37 1NE
|
|
Correspondent Contact |
LES TODD |
Regulation Number | 884.6110 |
Classification Product Code |
|
Date Received | 02/28/2000 |
Decision Date | 03/09/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|