Device Classification Name |
catheter, assisted reproduction
|
510(k) Number |
K994327 |
Device Name |
EMBRYON TRANSFER CATHETERS/SETS |
Applicant |
ROCKET MEDICAL PLC |
TYNE & WEAR |
WASHINGTON,
GB
NE37 1NE
|
|
Applicant Contact |
LES TODD |
Correspondent |
ROCKET MEDICAL PLC |
TYNE & WEAR |
WASHINGTON,
GB
NE37 1NE
|
|
Correspondent Contact |
LES TODD |
Regulation Number | 884.6110
|
Classification Product Code |
|
Date Received | 12/22/1999 |
Decision Date | 02/28/2000 |
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
|
|
|