Device Classification Name |
Neurosurgical Paddie
|
510(k) Number |
K121822 |
Device Name |
DELICOT |
Applicant |
AMERICAN SURGICAL COMPANY, LLC |
82 SANDERSON AVENUE |
LYNN,
MA
01902
|
|
Applicant Contact |
ERIK PIASIO |
Correspondent |
AMERICAN SURGICAL COMPANY, LLC |
82 SANDERSON AVENUE |
LYNN,
MA
01902
|
|
Correspondent Contact |
ERIK PIASIO |
Regulation Number | 882.4700
|
Classification Product Code |
|
Date Received | 06/21/2012 |
Decision Date | 09/10/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|