Device Classification Name |
Staple, Implantable
|
510(k) Number |
K993785 |
Device Name |
ULTRACLIP TISSUE MARKER |
Applicant |
INRAD |
3956 44TH ST., S.E. |
KENTWOOD,
MI
49512
|
|
Applicant Contact |
JOSEPH M MAZUREK |
Correspondent |
INRAD |
3956 44TH ST., S.E. |
KENTWOOD,
MI
49512
|
|
Correspondent Contact |
JOSEPH M MAZUREK |
Regulation Number | 878.4750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/08/1999 |
Decision Date | 02/04/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|