Device Classification Name |
needle, catheter
|
510(k) Number |
K854327 |
Device Name |
SUBCUTANEOUS TUNNELING NEEDLES & HANDLES |
Applicant |
CONCORD LABORATORIES, INC. |
KIT ST. |
KEENE,
NH
03431
|
|
Applicant Contact |
ROBERT WHEELER |
Correspondent |
CONCORD LABORATORIES, INC. |
KIT ST. |
KEENE,
NH
03431
|
|
Correspondent Contact |
ROBERT WHEELER |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 10/28/1985 |
Decision Date | 11/13/1985 |
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
|
|
|