Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyester
|
510(k) Number |
K904535 |
Device Name |
LU-TEX II |
Applicant |
LUKENS MEDICAL CORP. |
500 LASER RD. |
RIO RANCHO,
NM
87124
|
|
Applicant Contact |
M KELLY |
Correspondent |
LUKENS MEDICAL CORP. |
500 LASER RD. |
RIO RANCHO,
NM
87124
|
|
Correspondent Contact |
M KELLY |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 10/04/1990 |
Decision Date | 01/30/1991 |
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
|
|
|