Device Classification Name |
balloon, epistaxis
|
510(k) Number |
K993362 |
Device Name |
HYLASINE |
Applicant |
BIOMATRIX, INC. |
65 RAILROAD AVE. |
RIDGEFIELD,
NJ
07657
|
|
Applicant Contact |
MARIO J RERES |
Correspondent |
BIOMATRIX, INC. |
65 RAILROAD AVE. |
RIDGEFIELD,
NJ
07657
|
|
Correspondent Contact |
MARIO J RERES |
Regulation Number | 874.4100
|
Classification Product Code |
|
Date Received | 10/06/1999 |
Decision Date | 03/13/2000 |
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
|
|
|