Device Classification Name |
System, Vocal Cord Medialization
|
510(k) Number |
K983525 |
Device Name |
GORE REVOX THYROPLASTY IMPLANT |
Applicant |
W.L. GORE & ASSOCIATES,INC |
301 AIRPORT RD |
ELKTON,
MD
21922 -1408
|
|
Applicant Contact |
JOHN NICHOLSON |
Correspondent |
W.L. GORE & ASSOCIATES,INC |
301 AIRPORT RD |
ELKTON,
MD
21922 -1408
|
|
Correspondent Contact |
JOHN NICHOLSON |
Regulation Number | 874.3620
|
Classification Product Code |
|
Date Received | 10/08/1998 |
Decision Date | 12/10/1998 |
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
|
|
|