Device Classification Name |
retention device, suture
|
510(k) Number |
K863570 |
Device Name |
LE VEEN WOUND SPLINT |
Applicant |
TEK-AID, INC. |
1023 WAPPOO ROAD, SUITE 41-B |
CHARLESTON,
SC
29407
|
|
Applicant Contact |
SUSAN J SMOAK |
Correspondent |
TEK-AID, INC. |
1023 WAPPOO ROAD, SUITE 41-B |
CHARLESTON,
SC
29407
|
|
Correspondent Contact |
SUSAN J SMOAK |
Regulation Number | 878.4930
|
Classification Product Code |
|
Date Received | 09/12/1986 |
Decision Date | 09/29/1986 |
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
|
|
|