Device Classification Name |
lubricant, patient
|
510(k) Number |
K871169 |
Device Name |
LUBRICATING JELLY |
Applicant |
H & P INDUSTRIES, INC. |
9640 S 60TH ST. |
FRANKLIN,
WI
53132
|
|
Applicant Contact |
KISHOR DESAI |
Correspondent |
H & P INDUSTRIES, INC. |
9640 S 60TH ST. |
FRANKLIN,
WI
53132
|
|
Correspondent Contact |
KISHOR DESAI |
Regulation Number | 880.6375
|
Classification Product Code |
|
Date Received | 03/24/1987 |
Decision Date | 04/01/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|