Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K932855 |
Device Name |
HOLLISTER VERTICAL DRAIN/TUBE ATTACHMENT DEVICE |
Applicant |
HOLLISTER, INC. |
2000 HOLLISTER DR. |
LIBERTYVILLE,
IL
60048
|
|
Applicant Contact |
JOSEPH TOKARZ |
Correspondent |
HOLLISTER, INC. |
2000 HOLLISTER DR. |
LIBERTYVILLE,
IL
60048
|
|
Correspondent Contact |
JOSEPH TOKARZ |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 06/10/1993 |
Decision Date | 10/13/1993 |
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
|
|
|