Device Classification Name |
instrument, vitreous aspiration and cutting, ac-powered
|
510(k) Number |
K813389 |
Device Name |
ULTRASONIC FRAGMENTOR |
Applicant |
FIBRA SONICS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
FIBRA SONICS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 12/03/1981 |
Decision Date | 02/04/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|