Device Classification Name |
suture, absorbable, synthetic, polyglycolic acid
|
510(k) Number |
K060801 |
Device Name |
DEKNA-LOK MODEL BP1000V2L |
Applicant |
TELEFLEX MEDICAL |
2917 Weck Drive |
Research Triangle Park,
NC
27709
|
|
Applicant Contact |
KIMBERLY EDGERTON |
Correspondent |
TELEFLEX MEDICAL |
2917 Weck Drive |
Research Triangle Park,
NC
27709
|
|
Correspondent Contact |
KIMBERLY EDGERTON |
Regulation Number | 878.4493
|
Classification Product Code |
|
Date Received | 03/24/2006 |
Decision Date | 05/17/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|