Device Classification Name |
Tester, Auditory Impedance
|
510(k) Number |
K911095 |
Device Name |
GSI 37 AUTO TYMP |
Applicant |
LUCAS GRASON-STADLER, INC. |
537 GREAT RD. |
P.O. BOX 1400 |
LITTLETON,
MA
01460
|
|
Applicant Contact |
JANICE E PAINTER |
Correspondent |
LUCAS GRASON-STADLER, INC. |
537 GREAT RD. |
P.O. BOX 1400 |
LITTLETON,
MA
01460
|
|
Correspondent Contact |
JANICE E PAINTER |
Regulation Number | 874.1090
|
Classification Product Code |
|
Date Received | 03/13/1991 |
Decision Date | 03/29/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|