Device Classification Name |
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
|
510(k) Number |
K925024 |
Device Name |
ORC TAPPERED IRRIGATING PROBE |
Applicant |
O.R. CONCEPTS, INC. |
200 N. OAK ST. |
ROANOKE,
TX
76262
|
|
Applicant Contact |
JOHN MAYALL |
Correspondent |
O.R. CONCEPTS, INC. |
200 N. OAK ST. |
ROANOKE,
TX
76262
|
|
Correspondent Contact |
JOHN MAYALL |
Regulation Number | 878.4680
|
Classification Product Code |
|
Date Received | 10/02/1992 |
Decision Date | 05/21/1993 |
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
|
|
|