Device Classification Name |
curette, suction, endometrial (and accessories)
|
510(k) Number |
K974819 |
Device Name |
SELECTCELLS(TM) MINI |
Applicant |
SELECT MEDICAL SYSTEMS, INC. |
2 WINTERSPORT LN. |
WILLISTON,
VT
05495
|
|
Applicant Contact |
MONIQUE GIRARD |
Correspondent |
SELECT MEDICAL SYSTEMS, INC. |
2 WINTERSPORT LN. |
WILLISTON,
VT
05495
|
|
Correspondent Contact |
MONIQUE GIRARD |
Regulation Number | 884.1175
|
Classification Product Code |
|
Date Received | 12/23/1997 |
Decision Date | 03/23/1998 |
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
|
|
|