Device Classification Name |
sterilization wrap containers, trays, cassettes & other accessories
|
510(k) Number |
K102544 |
Device Name |
SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY |
Applicant |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
130 FORBES BLVD. |
MANSFIELD,
MA
02048
|
|
Applicant Contact |
KATHLEEN SOLOMON |
Correspondent |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
130 FORBES BLVD. |
MANSFIELD,
MA
02048
|
|
Correspondent Contact |
KATHLEEN SOLOMON |
Regulation Number | 880.6850
|
Classification Product Code |
|
Date Received | 09/03/2010 |
Decision Date | 01/05/2011 |
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
|
|
|