Device Classification Name |
laser, neurosurgical, argon
|
510(k) Number |
K864610 |
Device Name |
CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE |
Applicant |
INFRAMED, INC. |
100 CRESCENT RD. |
NEEDHAM,
MA
02194
|
|
Applicant Contact |
TIM SHEA |
Correspondent |
INFRAMED, INC. |
100 CRESCENT RD. |
NEEDHAM,
MA
02194
|
|
Correspondent Contact |
TIM SHEA |
Classification Product Code |
|
Date Received | 11/20/1986 |
Decision Date | 06/18/1987 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|