Device Classification Name |
Forceps, Obstetrical
|
510(k) Number |
K092827 |
Device Name |
DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX |
Applicant |
DIMEDA INSTRUMENTE GMBH |
SCHWARZWALDSTRABE 5 |
TUTTLINGEN,
DE
78532
|
|
Applicant Contact |
ANDREA PECSI |
Correspondent |
DIMEDA INSTRUMENTE GMBH |
SCHWARZWALDSTRABE 5 |
TUTTLINGEN,
DE
78532
|
|
Correspondent Contact |
ANDREA PECSI |
Regulation Number | 884.4400
|
Classification Product Code |
|
Date Received | 09/14/2009 |
Decision Date | 01/08/2010 |
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
|
|
|