Device Classification Name |
Balloon, Epistaxis
|
510(k) Number |
K972076 |
Device Name |
EPI-MAX EPISTAXIS CATHETER |
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 | 874.4100
|
Classification Product Code |
|
Date Received | 06/03/1997 |
Decision Date | 06/26/1997 |
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
|
|
|