Device Classification Name |
Plate, Cranioplasty, Preformed, Alterable
|
510(k) Number |
K903485 |
Device Name |
TITANIUM MESH |
Applicant |
RUGGLES CORP. |
38 BILLINGS RD. |
NO. QUINCY,
MA
02171
|
|
Applicant Contact |
ALLAN RUGGLES |
Correspondent |
RUGGLES CORP. |
38 BILLINGS RD. |
NO. QUINCY,
MA
02171
|
|
Correspondent Contact |
ALLAN RUGGLES |
Regulation Number | 882.5320
|
Classification Product Code |
|
Date Received | 07/31/1990 |
Decision Date | 02/21/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|