Device Classification Name |
Catheter, Cholangiography
|
510(k) Number |
K920643 |
Device Name |
LAPAROSCOPIC SUCTION/IRRIGATION 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 | 878.4200
|
Classification Product Code |
|
Date Received | 02/12/1992 |
Decision Date | 05/06/1992 |
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
|