Device Classification Name |
perineometer
|
510(k) Number |
K861858 |
Device Name |
VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363 |
Applicant |
PERITONE RESEARCH, LTD. |
75-04 249 ST. |
BELLEROSE,
NY
11426
|
|
Applicant Contact |
KAISER, PH.D. |
Correspondent |
PERITONE RESEARCH, LTD. |
75-04 249 ST. |
BELLEROSE,
NY
11426
|
|
Correspondent Contact |
KAISER, PH.D. |
Regulation Number | 884.1425
|
Classification Product Code |
|
Date Received | 05/14/1986 |
Decision Date | 07/31/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|