Device Classification Name |
Forceps, Obstetrical
|
510(k) Number |
K013747 |
Device Name |
TEKNO-MEDICAL OBSTETRICAL FORCEPS |
Applicant |
TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO. |
KAISERSTR 9 |
TUNINGEN, BADEN-WURTENBERG,
DE
78609
|
|
Applicant Contact |
MARKUS DENK |
Correspondent |
TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO. |
KAISERSTR 9 |
TUNINGEN, BADEN-WURTENBERG,
DE
78609
|
|
Correspondent Contact |
MARKUS DENK |
Regulation Number | 884.4400
|
Classification Product Code |
|
Date Received | 11/13/2001 |
Decision Date | 02/11/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|