Device Classification Name |
Wrap, Sterilization
|
510(k) Number |
K801331 |
Device Name |
AMPCO HYPERALIMENTATION SUBCLAVIAN TRAYS |
Applicant |
ASSOCIATED MEDICAL PRODUCTS CO. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
ASSOCIATED MEDICAL PRODUCTS CO. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 880.6850 |
Classification Product Code |
|
Date Received | 06/03/1980 |
Decision Date | 08/20/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|