Device Classification Name |
Pessary, Vaginal
|
510(k) Number |
K965040 |
Device Name |
INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL |
Applicant |
JOHNSON & JOHNSON MEDICAL, INC. |
2500 ARBROOK BLVD. |
P.O. BOX 90130 |
ARLINGTON,
TX
76004 -0130
|
|
Applicant Contact |
RALPH H LARSEN |
Correspondent |
JOHNSON & JOHNSON MEDICAL, INC. |
2500 ARBROOK BLVD. |
P.O. BOX 90130 |
ARLINGTON,
TX
76004 -0130
|
|
Correspondent Contact |
RALPH H LARSEN |
Regulation Number | 884.3575
|
Classification Product Code |
|
Date Received | 12/17/1996 |
Decision Date | 03/10/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|