Device Classification Name |
labware, assisted reproduction
|
510(k) Number |
K090429 |
Device Name |
NUNC IVF CENTERWELL AND ICSI DISHES |
Applicant |
THERMO FISHER SCIENTIFIC (NALGE NUNC INTL) |
75 PANORAMA CREEK DRIVE |
ROCHESTER,
NY
14625 -2385
|
|
Applicant Contact |
ROBERT PRESCOTT |
Correspondent |
THERMO FISHER SCIENTIFIC (NALGE NUNC INTL) |
75 PANORAMA CREEK DRIVE |
ROCHESTER,
NY
14625 -2385
|
|
Correspondent Contact |
ROBERT PRESCOTT |
Regulation Number | 884.6160
|
Classification Product Code |
|
Date Received | 02/19/2009 |
Decision Date | 09/18/2009 |
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
|
|
|