Device Classification Name |
Guide, Needle, Surgical
|
510(k) Number |
K904172 |
Device Name |
ACCUPLACE (TM) |
Applicant |
DLP, INC. |
P.O.BOX 409 |
620 WATSONS S.W. |
GRAND RAPIDS,
MI
49501
|
|
Applicant Contact |
ROGER BRINK |
Correspondent |
DLP, INC. |
P.O.BOX 409 |
620 WATSONS S.W. |
GRAND RAPIDS,
MI
49501
|
|
Correspondent Contact |
ROGER BRINK |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 09/11/1990 |
Decision Date | 11/21/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|