Device Classification Name |
cannula, sinus
|
510(k) Number |
K922145 |
Device Name |
SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS |
Applicant |
ATOS MEDICAL AB |
9229 CRANFORD DR. |
POTOMAC,
MD
20854
|
|
Applicant Contact |
R. J SLOMOFF |
Correspondent |
ATOS MEDICAL AB |
9229 CRANFORD DR. |
POTOMAC,
MD
20854
|
|
Correspondent Contact |
R. J SLOMOFF |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 05/07/1992 |
Decision Date | 01/21/1993 |
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
|