Device Classification Name |
laser, ophthalmic
|
510(k) Number |
K990665 |
Device Name |
BQ/BM INTEGRATED LASER DELIVERY SYSTEM |
Applicant |
AMERICAN LASER CORP. |
2417 SOUTH 3850 WEST |
SALT LAKE CITY,
UT
84120
|
|
Applicant Contact |
DANIEL HOEFER |
Correspondent |
AMERICAN LASER CORP. |
2417 SOUTH 3850 WEST |
SALT LAKE CITY,
UT
84120
|
|
Correspondent Contact |
DANIEL HOEFER |
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 03/02/1999 |
Decision Date | 05/17/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|