Device Classification Name |
Beads, Hydrophilic, For Wound Exudate Absorption
|
510(k) Number |
K905206 |
Device Name |
INCARE PINSITE DRESSING |
Applicant |
HOLLISTER, INC. |
2000 HOLLISTER DR. |
LIBERTYVILLE,
IL
60048
|
|
Applicant Contact |
SHARON A LEAF |
Correspondent |
HOLLISTER, INC. |
2000 HOLLISTER DR. |
LIBERTYVILLE,
IL
60048
|
|
Correspondent Contact |
SHARON A LEAF |
Regulation Number | 878.4018
|
Classification Product Code |
|
Date Received | 11/20/1990 |
Decision Date | 04/12/1991 |
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
|
|
|