Device Classification Name |
Gauze/Sponge, Internal, X-Ray Detectable
|
510(k) Number |
K790050 |
Device Name |
SPONGES, STANFORD STERILE LAP |
Applicant |
STANFORD PROFESSIONAL PRODUCTS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
STANFORD PROFESSIONAL PRODUCTS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4450
|
Classification Product Code |
|
Date Received | 01/10/1979 |
Decision Date | 01/17/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|