Device Classification Name |
prosthesis, nose, internal
|
510(k) Number |
K822130 |
Device Name |
FRANCIS NASAL TUBE |
Applicant |
TEKNA MED CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
TEKNA MED CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 878.3680
|
Classification Product Code |
|
Date Received | 07/19/1982 |
Decision Date | 10/13/1982 |
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
|
|
|