Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyamide
|
510(k) Number |
K930943 |
Device Name |
LUKENS NYLON SURGICAL SUTURE |
Applicant |
LUKENS MEDICAL CORP. |
THE LAHR CONSULTING GROUP,INC. |
ONE LETHBRIDGE PLAZA |
MAHWAH,
NJ
07430
|
|
Applicant Contact |
BRENDA KELLY |
Correspondent |
LUKENS MEDICAL CORP. |
THE LAHR CONSULTING GROUP,INC. |
ONE LETHBRIDGE PLAZA |
MAHWAH,
NJ
07430
|
|
Correspondent Contact |
BRENDA KELLY |
Regulation Number | 878.5020
|
Classification Product Code |
|
Date Received | 02/23/1993 |
Decision Date | 12/17/1993 |
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
|