Device Classification Name |
Applicator, Ent Drug
|
510(k) Number |
K984345 |
Device Name |
AROMAPATCH |
Applicant |
ENVIS, INC. |
25 HERTIAGE DR. |
ASHEVILLE,
NC
28806
|
|
Applicant Contact |
STEVE WOODY |
Correspondent |
ENVIS, INC. |
25 HERTIAGE DR. |
ASHEVILLE,
NC
28806
|
|
Correspondent Contact |
STEVE WOODY |
Regulation Number | 874.5220
|
Classification Product Code |
|
Date Received | 12/04/1998 |
Decision Date | 03/19/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|