Device Classification Name |
Methyl Methacrylate For Aneurysmorrhaphy
|
510(k) Number |
K873688 |
Device Name |
ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL |
Applicant |
DENTSPLY INTL. |
570 WEST COLLEGE AVE. |
P.O. BOX 872 |
YORK,
PA
17405
|
|
Applicant Contact |
JOHN SEMMELMAN |
Correspondent |
DENTSPLY INTL. |
570 WEST COLLEGE AVE. |
P.O. BOX 872 |
YORK,
PA
17405
|
|
Correspondent Contact |
JOHN SEMMELMAN |
Regulation Number | 882.5030
|
Classification Product Code |
|
Date Received | 09/10/1987 |
Decision Date | 10/26/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|