Device Classification Name |
system, vocal cord medialization
|
510(k) Number |
K972317 |
Device Name |
MONTGOMERY THYROPLASTY IMPLANT SYSTEM |
Applicant |
BOSTON MEDICAL PRODUCTS, INC. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
ROSINA ROBINSON |
Correspondent |
BOSTON MEDICAL PRODUCTS, INC. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
ROSINA ROBINSON |
Regulation Number | 874.3620
|
Classification Product Code |
|
Date Received | 06/20/1997 |
Decision Date | 09/18/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|