Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K912343 |
Device Name |
DISTENDABLE PALPATION PROBE |
Applicant |
DEXIDE, INC. |
P.O. BOX 185789 |
FT. WORTH,
TX
76181
|
|
Applicant Contact |
J.KEITH JUNG |
Correspondent |
DEXIDE, INC. |
P.O. BOX 185789 |
FT. WORTH,
TX
76181
|
|
Correspondent Contact |
J.KEITH JUNG |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 05/28/1991 |
Decision Date | 06/18/1991 |
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
|
|
|