Device Classification Name |
Unit, X-Ray, Extraoral With Timer
|
510(k) Number |
K930338 |
Device Name |
ORTHOCEPH OC100 |
Applicant |
INSTRUMENTARIUM CORP. |
P.O. BOX 20 (NAHKELENTIE 160) |
SF-04301 |
TUUSULA,
FI
|
|
Applicant Contact |
RISTO MYNTTINEN |
Correspondent |
INSTRUMENTARIUM CORP. |
P.O. BOX 20 (NAHKELENTIE 160) |
SF-04301 |
TUUSULA,
FI
|
|
Correspondent Contact |
RISTO MYNTTINEN |
Regulation Number | 872.1800
|
Classification Product Code |
|
Date Received | 01/25/1993 |
Decision Date | 04/27/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|