Device Classification Name |
apparatus, suction, single patient use, portable, nonpowered
|
510(k) Number |
K971036 |
Device Name |
ODONTIT AUTOGENOUS BONE COLLECTION DEVICE |
Applicant |
INTERPORE INTL. |
181 TECHNOLOGY DR. |
IRVINE,
CA
92618 -2402
|
|
Applicant Contact |
MARIO GERSBERG |
Correspondent |
INTERPORE INTL. |
181 TECHNOLOGY DR. |
IRVINE,
CA
92618 -2402
|
|
Correspondent Contact |
MARIO GERSBERG |
Regulation Number | 878.4680
|
Classification Product Code |
|
Date Received | 03/20/1997 |
Decision Date | 06/03/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|