Device Classification Name |
Balloon, Epistaxis
|
510(k) Number |
K920394 |
Device Name |
MEROCEL EPISTACIS KIT |
Applicant |
MEROCEL CORP. |
950 FLANDERS RD. |
MYSTIC,
CT
06355 -0334
|
|
Applicant Contact |
DOUGLAS R VALENTINE |
Correspondent |
MEROCEL CORP. |
950 FLANDERS RD. |
MYSTIC,
CT
06355 -0334
|
|
Correspondent Contact |
DOUGLAS R VALENTINE |
Regulation Number | 874.4100
|
Classification Product Code |
|
Date Received | 01/30/1992 |
Decision Date | 03/18/1993 |
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
|
|
|