Device Classification Name |
holder, needle, gastroenterologic
|
510(k) Number |
K920706 |
Device Name |
MAGNETIC POINT GUARD FOR SURGICAL NEEDLES |
Applicant |
RETRAX |
800 W. WAUSAU CIRCLE |
WAUSAU,
WI
54401
|
|
Applicant Contact |
DONALD KRANENDOBK |
Correspondent |
RETRAX |
800 W. WAUSAU CIRCLE |
WAUSAU,
WI
54401
|
|
Correspondent Contact |
DONALD KRANENDOBK |
Regulation Number | 876.4730
|
Classification Product Code |
|
Date Received | 02/18/1992 |
Decision Date | 05/26/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|