Device Classification Name |
sterilization wrap containers, trays, cassettes & other accessories
|
510(k) Number |
K133015 |
Device Name |
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM |
Applicant |
SUMMIT MEDICAL, INC. |
815 NORTHWEST PKWY, STE 100 |
st. paul,
MN
55121
|
|
Applicant Contact |
nicole dove |
Correspondent |
SUMMIT MEDICAL, INC. |
815 NORTHWEST PKWY, STE 100 |
st. paul,
MN
55121
|
|
Correspondent Contact |
nicole dove |
Regulation Number | 880.6850
|
Classification Product Code |
|
Date Received | 09/25/2013 |
Decision Date | 03/13/2014 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
statement |
statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|