Device Classification Name |
Osteotome
|
510(k) Number |
K874503 |
Device Name |
MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER |
Applicant |
MICRO-AIRE SURGICAL INSTRUMENTS, INC. |
505 FOURTH ST. |
SAN FERNANDO,
CA
91340
|
|
Applicant Contact |
SIDDHARTH DESAI |
Correspondent |
MICRO-AIRE SURGICAL INSTRUMENTS, INC. |
505 FOURTH ST. |
SAN FERNANDO,
CA
91340
|
|
Correspondent Contact |
SIDDHARTH DESAI |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 11/02/1987 |
Decision Date | 12/02/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|