Device Classification Name |
sterilization wrap containers, trays, cassettes & other accessories
|
510(k) Number |
K151166 |
Device Name |
Instru-Safe Instrument Protection System |
Applicant |
Summit Medical Inc. |
815 Northwest Parkway, Suite 100 |
St. Paul,
MN
55121
|
|
Applicant Contact |
Nicole Dove |
Correspondent |
Summit Medical Inc. |
815 Northwest Parkway, Suite 100 |
St. Paul,
MN
55121
|
|
Correspondent Contact |
Nicole Dove |
Regulation Number | 880.6850
|
Classification Product Code |
|
Date Received | 05/01/2015 |
Decision Date | 08/18/2015 |
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
|
|
|