Device Classification Name |
applier, hemostatic clip
|
510(k) Number |
K924929 |
Device Name |
REFLEX(R) ECA |
Applicant |
RICHARD-ALLAN MEDICAL |
8850M89, BOX 351 |
RICHLAND,
MI
49083
|
|
Applicant Contact |
JULIE POWELL |
Correspondent |
RICHARD-ALLAN MEDICAL |
8850M89, BOX 351 |
RICHLAND,
MI
49083
|
|
Correspondent Contact |
JULIE POWELL |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 09/30/1992 |
Decision Date | 07/21/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|