Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyethylene
|
510(k) Number |
K094028 |
Device Name |
CP-FIBER (ORTHOFIBER) |
Applicant |
CP MEDICAL |
803 NE 25TH AVE. |
PORTLAND,
OR
97232
|
|
Applicant Contact |
BARBARA K HORTON |
Correspondent |
CP MEDICAL |
803 NE 25TH AVE. |
PORTLAND,
OR
97232
|
|
Correspondent Contact |
BARBARA K HORTON |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 12/30/2009 |
Decision Date | 03/18/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|