Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K972058 |
Device Name |
LORIPRO, LORIPRO II |
Applicant |
LORI MEDICAL LABORATORIES, INC. |
696 MENDELSSOHN AVE. NORTH |
GOLDEN VALLEY,
MN
55427 -4306
|
|
Applicant Contact |
GARY MAAS |
Correspondent |
LORI MEDICAL LABORATORIES, INC. |
696 MENDELSSOHN AVE. NORTH |
GOLDEN VALLEY,
MN
55427 -4306
|
|
Correspondent Contact |
GARY MAAS |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 06/02/1997 |
Decision Date | 08/15/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|