Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K032838 |
Device Name |
CELON ENT SYSTEM |
Applicant |
CELON AG MEDICAL INSTRUMENTS |
8 RHEINSTRASSE |
TELTOW,
DE
14513
|
|
Applicant Contact |
ANDRE ROGGAN |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
12 LABORATORY DR. |
RESEARCH TRIANGLE,
NC
27709
|
|
Correspondent Contact |
PAMELA GWYNN |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 09/11/2003 |
Decision Date | 09/26/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|