Device Classification Name |
endoscopic irrigation/suction system
|
510(k) Number |
K953655 |
Device Name |
J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS |
Applicant |
JOHNSON & JOHNSON MEDICAL, INC. |
2500 ARBROOK BLVD. |
P.O. BOX 90130 |
ARLINGTON,
TX
76004 -0130
|
|
Applicant Contact |
WILLIAM P ROBB |
Correspondent |
JOHNSON & JOHNSON MEDICAL, INC. |
2500 ARBROOK BLVD. |
P.O. BOX 90130 |
ARLINGTON,
TX
76004 -0130
|
|
Correspondent Contact |
WILLIAM P ROBB |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/04/1995 |
Decision Date | 10/13/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|