Device Classification Name |
Needle, Aspiration And Injection, Disposable
|
510(k) Number |
K843925 |
Device Name |
GILL'S IRRIGATOR/ASPIRATOR NEEDLE |
Applicant |
CONCEPT, INC. |
12707 U.S. 19 SOUTH |
CLEARWATER,
FL
33546
|
|
Applicant Contact |
CARL A ANGLES |
Correspondent |
CONCEPT, INC. |
12707 U.S. 19 SOUTH |
CLEARWATER,
FL
33546
|
|
Correspondent Contact |
CARL A ANGLES |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 10/05/1984 |
Decision Date | 11/05/1984 |
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
|