Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K973376 |
Device Name |
LORI/LORI, LORI-S (LORI STOCK AID) |
Applicant |
LORI MEDICAL LABORATORIES, INC. |
696 MENDELSSOHN AVE. NORTH |
GOLDEN VALLEY,
MN
55427 -4306
|
|
Applicant Contact |
JIM HAMMARSTEDT |
Correspondent |
LORI MEDICAL LABORATORIES, INC. |
696 MENDELSSOHN AVE. NORTH |
GOLDEN VALLEY,
MN
55427 -4306
|
|
Correspondent Contact |
JIM HAMMARSTEDT |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 09/08/1997 |
Decision Date | 10/14/1997 |
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
|
|
|