Device Classification Name |
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
|
510(k) Number |
K121280 |
Device Name |
MYOSURE INTRUMENT TRAY |
Applicant |
HOLOGIC, INC. |
250 CAMPUS DRIVE |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
DANIEL F PHELAN |
Correspondent |
HOLOGIC, INC. |
250 CAMPUS DRIVE |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
DANIEL F PHELAN |
Regulation Number | 880.6850
|
Classification Product Code |
|
Date Received | 04/30/2012 |
Decision Date | 02/08/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|