Device Classification Name |
Arthroscope
|
510(k) Number |
K041454 |
Device Name |
KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A |
Applicant |
KYPHON, INC. |
1221 CROSSMAN AVE. |
SUNNYVALE,
CA
94089
|
|
Applicant Contact |
CINDY DOMESCUS |
Correspondent |
KYPHON, INC. |
1221 CROSSMAN AVE. |
SUNNYVALE,
CA
94089
|
|
Correspondent Contact |
CINDY DOMESCUS |
Regulation Number | 888.1100
|
Classification Product Code |
|
Date Received | 06/01/2004 |
Decision Date | 07/09/2004 |
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
|
|
|