Device Classification Name |
Curette, Uterine
|
510(k) Number |
K862297 |
Device Name |
THE D & C PAD-SAC |
Applicant |
NU-GYN-TEK, INC. |
P.O. BOX 75 |
OAKFIELD,
NY
14125
|
|
Applicant Contact |
JAEGER, M.D. |
Correspondent |
NU-GYN-TEK, INC. |
P.O. BOX 75 |
OAKFIELD,
NY
14125
|
|
Correspondent Contact |
JAEGER, M.D. |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 06/17/1986 |
Decision Date | 07/07/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|