| 510(k) Number |
K827379 |
| Device Name |
X-RAY CASSETTE |
| Applicant |
| Synchroplan Corp. |
| 32 W. 40th St. |
|
New York,
NY
10018
|
|
| Correspondent |
| Synchroplan Corp. |
| 32 W. 40th St. |
|
New York,
NY
10018
|
|
| Date Received | 04/19/1982 |
| Decision Date | 05/19/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|