Device Classification Name |
board, arm (with cover), sterile
|
510(k) Number |
K823412 |
Device Name |
ARM BOARD W/I.V COVERING |
Applicant |
SAGE PRODUCTS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
SAGE PRODUCTS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 878.3910
|
Classification Product Code |
|
Date Received | 11/15/1982 |
Decision Date | 12/15/1982 |
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
|
|
|