Device Classification Name |
microtools, assisted reproduction (pipettes)
|
510(k) Number |
K041435 |
Device Name |
THE STRIPPER PGD |
Applicant |
MID-ATLANTIC DIAGNOSTICS, INC. |
438 NORTH ELMWOOD RD. |
MARLTON,
NJ
08053
|
|
Applicant Contact |
SUSAN J BUSH |
Correspondent |
MID-ATLANTIC DIAGNOSTICS, INC. |
438 NORTH ELMWOOD RD. |
MARLTON,
NJ
08053
|
|
Correspondent Contact |
SUSAN J BUSH |
Regulation Number | 884.6130
|
Classification Product Code |
|
Date Received | 05/28/2004 |
Decision Date | 09/29/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|