Device Classification Name |
sterilization wrap containers, trays, cassettes & other accessories
|
510(k) Number |
K073551 |
Device Name |
SMITH & NEPHEW INSTRUMENT TRAYS |
Applicant |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
130 FORBES BLVD. |
MANSFIELD,
MA
02048
|
|
Applicant Contact |
JULIE ACKER |
Correspondent |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
130 FORBES BLVD. |
MANSFIELD,
MA
02048
|
|
Correspondent Contact |
JULIE ACKER |
Regulation Number | 880.6850
|
Classification Product Code |
|
Date Received | 12/18/2007 |
Decision Date | 05/21/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|