Device Classification Name |
Balloon, Epistaxis
|
510(k) Number |
K933800 |
Device Name |
FLUOROFILM(R) |
Applicant |
AMERICAN CUSTOM MEDICAL, INC. |
3403 73RD ST. |
LUBBOCK,
TX
79413
|
|
Applicant Contact |
BRUCE G RUEFER |
Correspondent |
AMERICAN CUSTOM MEDICAL, INC. |
3403 73RD ST. |
LUBBOCK,
TX
79413
|
|
Correspondent Contact |
BRUCE G RUEFER |
Regulation Number | 874.4100
|
Classification Product Code |
|
Date Received | 08/04/1993 |
Decision Date | 06/24/1994 |
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
|
|
|