Device Classification Name |
splint, intranasal septal
|
510(k) Number |
K935658 |
Device Name |
MEROCEL(R) TURBINATE GLOVE AND SEPTAL SPLINT |
Applicant |
MEROCEL CORP. |
950 FLANDERS RD. |
MYSTIC,
CT
06355 -0334
|
|
Applicant Contact |
JOHN GAGLIARDI |
Correspondent |
MEROCEL CORP. |
950 FLANDERS RD. |
MYSTIC,
CT
06355 -0334
|
|
Correspondent Contact |
JOHN GAGLIARDI |
Regulation Number | 874.4780
|
Classification Product Code |
|
Date Received | 11/24/1993 |
Decision Date | 03/04/1994 |
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
|
|
|