Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyester
|
510(k) Number |
K953128 |
Device Name |
SUTURE CORD |
Applicant |
PHOENIX BIOMEDICAL CORP. |
2495 GENERAL ARMSTEAD AVE. |
P.O. BOX 80390 |
VALLEY FORGE,
PA
19484
|
|
Applicant Contact |
HORACE J WILMER |
Correspondent |
PHOENIX BIOMEDICAL CORP. |
2495 GENERAL ARMSTEAD AVE. |
P.O. BOX 80390 |
VALLEY FORGE,
PA
19484
|
|
Correspondent Contact |
HORACE J WILMER |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 07/06/1995 |
Decision Date | 02/09/1996 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|