| Device Classification Name |
System, Communication, Non-Powered
|
| 510(k) Number |
K823608 |
| Device Name |
PICTURES & WORD IDENTIFICATION CVA PAT |
| Applicant |
| FRED SAMMONS, INC. |
| 4221 Richmond Rd., N.W. |
|
Walker,
MI
49534
|
|
| Correspondent |
| FRED SAMMONS, INC. |
| 4221 Richmond Rd., N.W. |
|
Walker,
MI
49534
|
|
| Regulation Number | 890.3700 |
| Classification Product Code |
|
| Date Received | 12/06/1982 |
| Decision Date | 12/30/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Physical Medicine
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|