Device Classification Name |
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
|
510(k) Number |
K953013 |
Device Name |
MEROCEL REINFORCED SILICONE SHEETS |
Applicant |
MEROCEL CORP. |
6743 SOUTHPOINT DRIVE NORTH |
JACKSONVILLE,
FL
32216
|
|
Applicant Contact |
DAVID TIMLIN |
Correspondent |
MEROCEL CORP. |
6743 SOUTHPOINT DRIVE NORTH |
JACKSONVILLE,
FL
32216
|
|
Correspondent Contact |
DAVID TIMLIN |
Regulation Number | 874.3620
|
Classification Product Code |
|
Date Received | 06/29/1995 |
Decision Date | 08/29/1995 |
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
|
|
|