Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K003226 |
Device Name |
THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM |
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 | 10/16/2000 |
Decision Date | 01/12/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|