Device Classification Name |
Locator, Root Apex
|
510(k) Number |
K002195 |
Device Name |
FORAMATRON V, MODEL D680 |
Applicant |
PARKELL, INC. |
155 SCHMITT BLVD. |
P.O. BOX 376 |
FARMINGDALE,
NY
11735
|
|
Applicant Contact |
DANIEL R SCHECHTER |
Correspondent |
PARKELL, INC. |
155 SCHMITT BLVD. |
P.O. BOX 376 |
FARMINGDALE,
NY
11735
|
|
Correspondent Contact |
DANIEL R SCHECHTER |
Classification Product Code |
|
Date Received | 07/20/2000 |
Decision Date | 08/30/2000 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|