Device Classification Name |
Counter, Sponge, Surgical
|
510(k) Number |
K061316 |
Device Name |
MEDLINE SURGICAL SPONGE SCANNER |
Applicant |
MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE |
MUNDELEIN,
IL
60060
|
|
Applicant Contact |
LARA N SIMMONS |
Correspondent |
MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE |
MUNDELEIN,
IL
60060
|
|
Correspondent Contact |
LARA N SIMMONS |
Regulation Number | 880.2740
|
Classification Product Code |
|
Date Received | 05/11/2006 |
Decision Date | 11/02/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|