Device Classification Name |
Balloon, Epistaxis
|
510(k) Number |
K954845 |
Device Name |
EXPANDACELL INJECTO-PAK NASAL PACK |
Applicant |
SHIPPERT MEDICAL TECHNOLOGIES CORP. |
7002 SOUTH REVERE PKWY. |
SUITE 60 |
ENGLEWOOD,
CO
80112
|
|
Applicant Contact |
SARAH M LAKE |
Correspondent |
SHIPPERT MEDICAL TECHNOLOGIES CORP. |
7002 SOUTH REVERE PKWY. |
SUITE 60 |
ENGLEWOOD,
CO
80112
|
|
Correspondent Contact |
SARAH M LAKE |
Regulation Number | 874.4100
|
Classification Product Code |
|
Date Received | 10/23/1995 |
Decision Date | 11/27/1995 |
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
|
|
|