Device Classification Name |
Bone Grafting Material, Synthetic
|
510(k) Number |
K972842 |
Device Name |
INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE |
Applicant |
INTERPORE INTL. |
181 TECHNOLOGY DR. |
IRVINE,
CA
92618 -2402
|
|
Applicant Contact |
DAVID P BALDING |
Correspondent |
INTERPORE INTL. |
181 TECHNOLOGY DR. |
IRVINE,
CA
92618 -2402
|
|
Correspondent Contact |
DAVID P BALDING |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 08/01/1997 |
Decision Date | 10/30/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|