Device Classification Name |
gauze/sponge, internal, x-ray detectable
|
510(k) Number |
K813595 |
Device Name |
PARKE-DAVIS AEGIS ABOSRBENT SPONGES |
Applicant |
DESERET MEDICAL, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
DESERET MEDICAL, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4450
|
Classification Product Code |
|
Date Received | 12/28/1981 |
Decision Date | 01/18/1982 |
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
|