Device Classification Name |
Laser, Ophthalmic
|
510(k) Number |
K782106 |
Device Name |
COAGULATOR, MODEL 40 AARGON |
Applicant |
LASERTEK OY |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
LASERTEK OY |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 12/13/1978 |
Decision Date | 02/08/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|