Device Classification Name |
Suture, Absorbable, Natural
|
510(k) Number |
K896554 |
Device Name |
GUT SUTURES |
Applicant |
LOOK, INC. |
WASHINGTON SQUARE |
1050 CONNECTICUT AVENUE N.W. |
WASHINGTON,
DC
20036
|
|
Applicant Contact |
JOHN M PACKMAN |
Correspondent |
LOOK, INC. |
WASHINGTON SQUARE |
1050 CONNECTICUT AVENUE N.W. |
WASHINGTON,
DC
20036
|
|
Correspondent Contact |
JOHN M PACKMAN |
Regulation Number | 878.4830
|
Classification Product Code |
|
Date Received | 11/17/1989 |
Decision Date | 05/31/1990 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|