| Device Classification Name |
Film, Radiographic
|
| 510(k) Number |
K844554 |
| Device Name |
BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG |
| Applicant |
| Belmont Equipment Corp. |
| One Belmont Dr. |
|
Somerset,
NJ
08873
|
|
| Applicant Contact |
JOHN M GARDELLA |
| Correspondent |
| Belmont Equipment Corp. |
| One Belmont Dr. |
|
Somerset,
NJ
08873
|
|
| Correspondent Contact |
JOHN M GARDELLA |
| Regulation Number | 892.1840 |
| Classification Product Code |
|
| Date Received | 11/21/1984 |
| Decision Date | 02/21/1985 |
| 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
|
|
|