Device Classification Name |
system, abortion, vacuum
|
510(k) Number |
K030935 |
Device Name |
BERKELEY V-10 VACUUM CURETTAGE SYSTEM |
Applicant |
ACMI CORPORATION |
136 TURNPIKE RD. |
SOUTHBOROUGH,
MA
01772
|
|
Applicant Contact |
FRANK FUCILE |
Correspondent |
ACMI CORPORATION |
136 TURNPIKE RD. |
SOUTHBOROUGH,
MA
01772
|
|
Correspondent Contact |
FRANK FUCILE |
Regulation Number | 884.5070
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/25/2003 |
Decision Date | 06/23/2003 |
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
|
Recalls |
CDRH Recalls
|
|
|