Device Classification Name |
Device, Surgical, Cryogenic
|
510(k) Number |
K781302 |
Device Name |
NEUROSTAT, LLOYD |
Applicant |
SPEMBLY MEDICAL LTD. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
SPEMBLY MEDICAL LTD. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 882.4250
|
Classification Product Code |
|
Date Received | 07/28/1978 |
Decision Date | 08/15/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|