Device Classification Name |
Board, Arm (With Cover), Sterile
|
510(k) Number |
K811419 |
Device Name |
SPRIO-LOOP |
Applicant |
DATAMED, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
DATAMED, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 878.3910
|
Classification Product Code |
|
Date Received | 05/19/1981 |
Decision Date | 06/12/1981 |
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
|
|
|