Device Classification Name |
Extractor, Vacuum, Fetal
|
510(k) Number |
K013460 |
Device Name |
SWIFT LOW PROFILE CUP (PRO CUP) |
Applicant |
SWIFT DELIVERY PRODUCTS |
6824 ELK CANYON RD. |
OKLAHOMA CITY,
OK
73162
|
|
Applicant Contact |
RICHARD G LINDSAY |
Correspondent |
SWIFT DELIVERY PRODUCTS |
6824 ELK CANYON RD. |
OKLAHOMA CITY,
OK
73162
|
|
Correspondent Contact |
RICHARD G LINDSAY |
Regulation Number | 884.4340
|
Classification Product Code |
|
Date Received | 10/18/2001 |
Decision Date | 01/17/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|