Device Classification Name |
apparatus, suction, single patient use, portable, nonpowered
|
510(k) Number |
K930615 |
Device Name |
AUTOVAC CLOSED WOUND SUCTION SYSTEM |
Applicant |
BOEHRINGER LABORATORIES |
P.O. BOX 870 |
NORRISTOWN,
PA
19404
|
|
Applicant Contact |
JOHN KARPOWICZ |
Correspondent |
BOEHRINGER LABORATORIES |
P.O. BOX 870 |
NORRISTOWN,
PA
19404
|
|
Correspondent Contact |
JOHN KARPOWICZ |
Regulation Number | 878.4680
|
Classification Product Code |
|
Date Received | 02/05/1993 |
Decision Date | 02/22/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|