Device Classification Name |
Cannula, Intrauterine Insemination
|
510(k) Number |
K982628 |
Device Name |
MEDWORKS INSEMINATION CATHETER |
Applicant |
MEDWORKS CORP. |
50 BREWSTER ST. |
PAWTUCKET,
RI
02860
|
|
Applicant Contact |
PAMELA PAPINEAU |
Correspondent |
MEDWORKS CORP. |
50 BREWSTER ST. |
PAWTUCKET,
RI
02860
|
|
Correspondent Contact |
PAMELA PAPINEAU |
Regulation Number | 884.5250
|
Classification Product Code |
|
Date Received | 07/28/1998 |
Decision Date | 08/21/1998 |
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
|
|
|