Device Classification Name |
implant, endosseous, root-form
|
510(k) Number |
K002037 |
Device Name |
LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS |
Applicant |
LIFECORE BIOMEDICAL, INC. |
3515 LYMAN BLVD. |
CHASKA,
MN
55318
|
|
Applicant Contact |
CAROLYN ANDERSON |
Correspondent |
LIFECORE BIOMEDICAL, INC. |
3515 LYMAN BLVD. |
CHASKA,
MN
55318
|
|
Correspondent Contact |
CAROLYN ANDERSON |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 07/05/2000 |
Decision Date | 05/16/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|