Device Classification Name |
Balloon, Epistaxis
|
510(k) Number |
K912524 |
Device Name |
EXPANDACEL NASAL TAMPONS, MODIFICATION |
Applicant |
SURGITREND, LTD. |
6099 SOUTH QUEBEC ST. #200 |
ENGLEWOOD,
CO
80111
|
|
Applicant Contact |
RON SHIPPERET |
Correspondent |
SURGITREND, LTD. |
6099 SOUTH QUEBEC ST. #200 |
ENGLEWOOD,
CO
80111
|
|
Correspondent Contact |
RON SHIPPERET |
Regulation Number | 874.4100
|
Classification Product Code |
|
Date Received | 06/03/1991 |
Decision Date | 08/15/1991 |
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
|
|
|