Device Classification Name |
Wrap, Sterilization
|
510(k) Number |
K080558 |
Device Name |
STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS |
Applicant |
CASE MEDICAL, INC. |
65 RAILROAD AVE. |
RIDGEFIELD,
NJ
07657 -0402
|
|
Applicant Contact |
TANIA LUPU |
Correspondent |
CASE MEDICAL, INC. |
65 RAILROAD AVE. |
RIDGEFIELD,
NJ
07657 -0402
|
|
Correspondent Contact |
TANIA LUPU |
Regulation Number | 880.6850
|
Classification Product Code |
|
Date Received | 02/28/2008 |
Decision Date | 12/05/2008 |
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
|
Recalls |
CDRH Recalls
|
|
|