Device Classification Name |
prosthesis, larynx (stents and keels)
|
510(k) Number |
K091135 |
FOIA Releasable 510(k) |
K091135
|
Device Name |
RUTTER SUPRA STOMAL STENTS |
Applicant |
BOSTON MEDICAL PRODUCTS, INC. |
117 FLANDERS RD. |
WESTBOROUGH,
MA
01581
|
|
Applicant Contact |
MICHAEL A WARREN |
Correspondent |
BOSTON MEDICAL PRODUCTS, INC. |
117 FLANDERS RD. |
WESTBOROUGH,
MA
01581
|
|
Correspondent Contact |
MICHAEL A WARREN |
Regulation Number | 874.3620
|
Classification Product Code |
|
Date Received | 04/20/2009 |
Decision Date | 09/14/2009 |
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
|
|
|