Device Classification Name |
Wound Dressing With Animal-Derived Material(S)
|
510(k) Number |
K003134 |
Device Name |
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING |
Applicant |
ADRI/TECHNAM |
P.O. BOX 134 |
PARK FOREST,
IL
60466
|
|
Applicant Contact |
GEORGE H SCHERR |
Correspondent |
ADRI/TECHNAM |
P.O. BOX 134 |
PARK FOREST,
IL
60466
|
|
Correspondent Contact |
GEORGE H SCHERR |
Classification Product Code |
|
Date Received | 10/06/2000 |
Decision Date | 12/22/2000 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|