Device Classification Name |
gauze/sponge, internal, x-ray detectable
|
510(k) Number |
K830202 |
Device Name |
COTTON BALLS, X-RAY OPAQUED STRUNG & NON |
Applicant |
AMERICAN MEDICAL DISPOSABLE, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
AMERICAN MEDICAL DISPOSABLE, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4450
|
Classification Product Code |
|
Date Received | 01/20/1983 |
Decision Date | 02/23/1983 |
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
|