Device Classification Name |
device, fertility diagnostic, proceptive
|
510(k) Number |
K813497 |
Device Name |
RHYTHM WHEEL |
Applicant |
TROPICAL ENTERPRISES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
TROPICAL ENTERPRISES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Classification Product Code |
|
Date Received | 12/14/1981 |
Decision Date | 05/03/1982 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|