Device Classification Name |
extractor, vacuum, fetal
|
510(k) Number |
K043614 |
Device Name |
VACULINK, MODEL VCL 3000 |
Applicant |
MEDEVCO, INC. |
2300 MCDERMOTT RD. |
#200-207 |
PLANO,
TX
75025
|
|
Applicant Contact |
KRISTA OAKES |
Correspondent |
MEDEVCO, INC. |
2300 MCDERMOTT RD. |
#200-207 |
PLANO,
TX
75025
|
|
Correspondent Contact |
KRISTA OAKES |
Regulation Number | 884.4340
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/30/2004 |
Decision Date | 04/14/2005 |
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
|
|
|