Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyethylene
|
510(k) Number |
K092533 |
Device Name |
FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES |
Applicant |
BEERE PRECISION MEDICAL INSTRUMENTS, KMEDIC, TELEF |
5307 95TH AVE. |
KENOSHA,
WI
53144
|
|
Applicant Contact |
JOY VOIGT |
Correspondent |
BEERE PRECISION MEDICAL INSTRUMENTS, KMEDIC, TELEF |
5307 95TH AVE. |
KENOSHA,
WI
53144
|
|
Correspondent Contact |
JOY VOIGT |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 08/19/2009 |
Decision Date | 09/15/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|