Device Classification Name |
tube, tympanostomy
|
510(k) Number |
K936275 |
Device Name |
TYMPOVENT |
Applicant |
ATOS MEDICAL AB |
P.O. BOX 183 |
HORBY, SWEDEN,
SE
SE-24222
|
|
Applicant Contact |
KARL-ERIK KARLSON |
Correspondent |
ATOS MEDICAL AB |
P.O. BOX 183 |
HORBY, SWEDEN,
SE
SE-24222
|
|
Correspondent Contact |
KARL-ERIK KARLSON |
Regulation Number | 874.3880
|
Classification Product Code |
|
Date Received | 12/30/1993 |
Decision Date | 05/05/1994 |
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
|
|
|