| Device Classification Name |
Cassette, Radiographic Film
|
| 510(k) Number |
K930244 |
| Device Name |
JPI X-RAY FILM CASSETTE |
| Applicant |
| Jpi, Inc. |
| 350-J Central Ave. |
|
Bohemia,
NY
11716
|
|
| Applicant Contact |
WILIAM HAGUE |
| Correspondent |
| Jpi, Inc. |
| 350-J Central Ave. |
|
Bohemia,
NY
11716
|
|
| Correspondent Contact |
WILIAM HAGUE |
| Regulation Number | 892.1850 |
| Classification Product Code |
|
| Date Received | 01/19/1993 |
| Decision Date | 04/07/1993 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Radiology
|
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|