Device Classification Name |
wrap, sterilization
|
510(k) Number |
K150698 |
Device Name |
Gemini Sterilization Wrap |
Applicant |
MEDLINE INDUSTRIES, INC. |
1 MEDLINE PLACE |
MUNDELEIN,
IL
60060
|
|
Applicant Contact |
Jennifer Mason |
Correspondent |
MEDLINE INDUSTRIES, INC. |
1 MEDLINE PLACE |
MUNDELEIN,
IL
60060
|
|
Correspondent Contact |
Jennifer Mason |
Regulation Number | 880.6850
|
Classification Product Code |
|
Date Received | 03/18/2015 |
Decision Date | 11/20/2015 |
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
|
|
|