Device Classification Name |
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
|
510(k) Number |
K920819 |
Device Name |
ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN |
Applicant |
ASTRA MEDITEC AB |
P.O. BOX 14 |
S-4321 21 MOLNDAL |
SWEDEN,
SE
|
|
Applicant Contact |
GOSTA WENNERSTORM |
Correspondent |
ASTRA MEDITEC AB |
P.O. BOX 14 |
S-4321 21 MOLNDAL |
SWEDEN,
SE
|
|
Correspondent Contact |
GOSTA WENNERSTORM |
Regulation Number | 878.4680
|
Classification Product Code |
|
Date Received | 02/24/1992 |
Decision Date | 03/24/1993 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|