Device Classification Name |
suture, absorbable, natural
|
510(k) Number |
K021043 |
Device Name |
GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC |
Applicant |
GRAMSMED LLC |
2225 DAKOTA DR. |
GRAFTON,
WI
53024
|
|
Applicant Contact |
ANTHONY J DIMERCURIO |
Correspondent |
GRAMSMED LLC |
2225 DAKOTA DR. |
GRAFTON,
WI
53024
|
|
Correspondent Contact |
ANTHONY J DIMERCURIO |
Regulation Number | 878.4830
|
Classification Product Code |
|
Date Received | 04/01/2002 |
Decision Date | 06/21/2002 |
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
|