Device Classification Name |
jelly, lubricating, for transurethral surgical instrument
|
510(k) Number |
K912132 |
Device Name |
OPERAND LUBRICATING JELLY |
Applicant |
GENERAL MEDICAL CO. |
P.O. BOX 237 |
PRICHARD INDUSTRIAL PARK |
PRICHARD,
WV
25555
|
|
Applicant Contact |
RICHARD J MARSHALL |
Correspondent |
GENERAL MEDICAL CO. |
P.O. BOX 237 |
PRICHARD INDUSTRIAL PARK |
PRICHARD,
WV
25555
|
|
Correspondent Contact |
RICHARD J MARSHALL |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 05/14/1991 |
Decision Date | 08/07/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|