Device Classification Name |
stapler, surgical
|
510(k) Number |
K933901 |
Device Name |
REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER) |
Applicant |
RICHARD-ALLAN MEDICAL |
8850 M89, BOX 351 |
RICHLAND,
MI
49083 -0351
|
|
Applicant Contact |
JULIE POWELL |
Correspondent |
RICHARD-ALLAN MEDICAL |
8850 M89, BOX 351 |
RICHLAND,
MI
49083 -0351
|
|
Correspondent Contact |
JULIE POWELL |
Regulation Number | 878.4740
|
Classification Product Code |
|
Date Received | 08/10/1993 |
Decision Date | 11/19/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|