Device Classification Name |
prosthesis, larynx (stents and keels)
|
510(k) Number |
K962693 |
Device Name |
MONTGOMERY RADIOPAQUE LARYNGEAL KEEL |
Applicant |
BOSTON MEDICAL PRODUCTS, INC. |
117 FLANDERS RD. |
WESTBOROUGH,
MA
01581
|
|
Applicant Contact |
STUART K MONTGOMERY |
Correspondent |
BOSTON MEDICAL PRODUCTS, INC. |
117 FLANDERS RD. |
WESTBOROUGH,
MA
01581
|
|
Correspondent Contact |
STUART K MONTGOMERY |
Regulation Number | 874.3620
|
Classification Product Code |
|
Date Received | 07/11/1996 |
Decision Date | 08/09/1996 |
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
|
|
|