Device Classification Name |
curette, suction, endometrial (and accessories)
|
510(k) Number |
K812426 |
Device Name |
UTERINE ASPIRATION CURETTES(RIGID&FLEX) |
Applicant |
MEDI-SPEC |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
MEDI-SPEC |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 884.1175
|
Classification Product Code |
|
Date Received | 08/25/1981 |
Decision Date | 10/08/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|