Device Classification Name |
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
|
510(k) Number |
K915536 |
Device Name |
DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC |
Applicant |
DAVOL, INC. |
100 SOCKANOSSETT CROSSROAD |
P.O. BOX 8500 |
CRANSTON,
RI
02920
|
|
Applicant Contact |
ANNETTE M FAGNANT |
Correspondent |
DAVOL, INC. |
100 SOCKANOSSETT CROSSROAD |
P.O. BOX 8500 |
CRANSTON,
RI
02920
|
|
Correspondent Contact |
ANNETTE M FAGNANT |
Regulation Number | 878.4680
|
Classification Product Code |
|
Date Received | 12/10/1991 |
Decision Date | 03/26/1992 |
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
|
|
|