Device Classification Name |
Suture, Absorbable, Synthetic, Polyglycolic Acid
|
510(k) Number |
K010672 |
Device Name |
MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE |
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 | 878.4493
|
Classification Product Code |
|
Date Received | 03/06/2001 |
Decision Date | 05/18/2001 |
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
|