Device Classification Name |
Arthroscope
|
510(k) Number |
K981251 |
Device Name |
KYPHON INFLATABLE BONE TAMP |
Applicant |
KYPHON, INC. |
3110 CORONADO DR. |
SANTA CLARA,
CA
95054
|
|
Applicant Contact |
KAREN TALMADGE |
Correspondent |
KYPHON, INC. |
3110 CORONADO DR. |
SANTA CLARA,
CA
95054
|
|
Correspondent Contact |
KAREN TALMADGE |
Regulation Number | 888.1100
|
Classification Product Code |
|
Date Received | 04/06/1998 |
Decision Date | 07/02/1998 |
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
|
|
|