Device Classification Name |
Media, Reproductive
|
510(k) Number |
K980814 |
FOIA Releasable 510(k) |
K980814
|
Device Name |
PURESPERM |
Applicant |
NIDACON INTERNATIONAL AB |
P.O. BOX 7007 |
DEERFIELD,
IL
60015
|
|
Applicant Contact |
DANIEL KAMM |
Correspondent |
NIDACON INTERNATIONAL AB |
P.O. BOX 7007 |
DEERFIELD,
IL
60015
|
|
Correspondent Contact |
DANIEL KAMM |
Regulation Number | 884.6180
|
Classification Product Code |
|
Date Received | 03/03/1998 |
Decision Date | 06/23/1998 |
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
|
|
|