Device Classification Name |
Gauze/Sponge, Internal, X-Ray Detectable
|
510(k) Number |
K781818 |
Device Name |
LAPARATOMY SPONGE |
Applicant |
MEDEN MEDICAL SALES DIVISION |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
MEDEN MEDICAL SALES DIVISION |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4450
|
Classification Product Code |
|
Date Received | 10/27/1978 |
Decision Date | 11/15/1978 |
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
|