Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K974336 |
Device Name |
CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC. |
Applicant |
J-LLOYD MEDICAL, INC. |
415 COMMERCE LN., SUITE 6 |
WEST BERLIN,
NJ
08091
|
|
Applicant Contact |
JAMES L SKAGGS |
Correspondent |
J-LLOYD MEDICAL, INC. |
415 COMMERCE LN., SUITE 6 |
WEST BERLIN,
NJ
08091
|
|
Correspondent Contact |
JAMES L SKAGGS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/18/1997 |
Decision Date | 02/13/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|