Device Classification Name |
Fastener, Fixation, Nondegradable, Soft Tissue
|
510(k) Number |
K120942 |
Device Name |
PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC |
Applicant |
PARCUS MEDICAL, LLC |
839 SOUTH NEENAH AVE. |
STURGEON BAY,
WI
54235
|
|
Applicant Contact |
PAUL VAGTS |
Correspondent |
PARCUS MEDICAL, LLC |
839 SOUTH NEENAH AVE. |
STURGEON BAY,
WI
54235
|
|
Correspondent Contact |
PAUL VAGTS |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 03/29/2012 |
Decision Date | 04/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|