Device Classification Name |
Nasopharyngoscope (Flexible Or Rigid)
|
510(k) Number |
K982594 |
Device Name |
ENDO-SCRUB/ENDO-SCRUB 2 |
Applicant |
XOMED, INC. |
6743 SOUTHPOINT DR. NORTH |
JACKSONVILLE,
FL
32216 -0980
|
|
Applicant Contact |
DEBRA B CORTNER |
Correspondent |
XOMED, INC. |
6743 SOUTHPOINT DR. NORTH |
JACKSONVILLE,
FL
32216 -0980
|
|
Correspondent Contact |
DEBRA B CORTNER |
Regulation Number | 874.4760
|
Classification Product Code |
|
Date Received | 07/24/1998 |
Decision Date | 08/27/1998 |
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
|
Recalls |
CDRH Recalls
|
|
|