Device Classification Name |
wrap, sterilization
|
510(k) Number |
K030853 |
Device Name |
STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI |
Applicant |
CASE MEDICAL, INC. |
65 RAILROAD AVE. |
RIDGEFIELD,
NJ
07657 -0402
|
|
Applicant Contact |
MARCIA FRIEZE |
Correspondent |
CASE MEDICAL, INC. |
65 RAILROAD AVE. |
RIDGEFIELD,
NJ
07657 -0402
|
|
Correspondent Contact |
Tania Lupu |
Regulation Number | 880.6850
|
Classification Product Code |
|
Date Received | 03/18/2003 |
Decision Date | 03/21/2003 |
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
|
|
|