Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K935207 |
Device Name |
ENDOFLUSH SYSTEM 1.0, 2.O, 3.0 |
Applicant |
SPECIALTY MEDICAL SYSTEMS, INC. |
P.O. BOX 16598 |
FT. WORTH,
TX
76162 -0598
|
|
Applicant Contact |
RICHARD A HAMER |
Correspondent |
SPECIALTY MEDICAL SYSTEMS, INC. |
P.O. BOX 16598 |
FT. WORTH,
TX
76162 -0598
|
|
Correspondent Contact |
RICHARD A HAMER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/29/1993 |
Decision Date | 04/21/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|