Device Classification Name |
plate, bone
|
510(k) Number |
K002083 |
Device Name |
LORENZ RESORBABLE DISTRACTOR SYSTEM |
Applicant |
WALTER LORENZ SURGICAL, INC. |
1520 TRADEPORT DR. |
JACKSONVILLE,
FL
32218
|
|
Applicant Contact |
STEVE HERRINGTON |
Correspondent |
WALTER LORENZ SURGICAL, INC. |
1520 TRADEPORT DR. |
JACKSONVILLE,
FL
32218
|
|
Correspondent Contact |
STEVE HERRINGTON |
Regulation Number | 872.4760
|
Classification Product Code |
|
Date Received | 07/10/2000 |
Decision Date | 02/12/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|