Device Classification Name |
Staple, Implantable
|
510(k) Number |
K922186 |
FOIA Releasable 510(k) |
K922186
|
Device Name |
HEM-O-LOK -- MODIFICATION |
Applicant |
LINVATEC CORP. |
P.O. BOX 12600 WECK DR. |
RESEARCH TRIANGLE PARK,
NC
27709
|
|
Applicant Contact |
GLENN M MATTEI |
Correspondent |
LINVATEC CORP. |
P.O. BOX 12600 WECK DR. |
RESEARCH TRIANGLE PARK,
NC
27709
|
|
Correspondent Contact |
GLENN M MATTEI |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 02/27/1992 |
Decision Date | 08/06/1992 |
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
|