Device Classification Name |
filler, bone void, calcium compound
|
510(k) Number |
K050025 |
Device Name |
NANOSS BONE VOID FILLER |
Applicant |
ANGSTROM MEDICA, INC. |
4329 GRAYDON ROAD |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
FLOYD G LARSON |
Correspondent |
ANGSTROM MEDICA, INC. |
4329 GRAYDON ROAD |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
FLOYD G LARSON |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 01/06/2005 |
Decision Date | 02/03/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|