Device Classification Name |
component, traction, invasive
|
510(k) Number |
K984442 |
Device Name |
AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 |
Applicant |
HAND BIOMECHANICS LAB, INC. |
77 SCRIPPS DR., SUITE 104 |
SACRAMENTO,
CA
95825
|
|
Applicant Contact |
TIMOTHY STALLINGS |
Correspondent |
HAND BIOMECHANICS LAB, INC. |
77 SCRIPPS DR., SUITE 104 |
SACRAMENTO,
CA
95825
|
|
Correspondent Contact |
TIMOTHY STALLINGS |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 12/14/1998 |
Decision Date | 02/12/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|