Device Classification Name |
Clip, Implantable
|
510(k) Number |
K981239 |
Device Name |
DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS |
Applicant |
DEROYAL SURGICAL |
185 RICHARDSON WAY |
MAYNARDVILLE,
TN
37807
|
|
Applicant Contact |
CAMILLE MATLOCK |
Correspondent |
DEROYAL SURGICAL |
185 RICHARDSON WAY |
MAYNARDVILLE,
TN
37807
|
|
Correspondent Contact |
CAMILLE MATLOCK |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 04/03/1998 |
Decision Date | 05/14/1998 |
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
|