Device Classification Name |
suture, absorbable, natural
|
510(k) Number |
K030227 |
Device Name |
SUTURTEK FASTCLOSE SUTURING DEVICE |
Applicant |
SUTURTEK INCORPORATED |
7 TIFFANY TRAIL |
HOPKINTON,
MA
01748
|
|
Applicant Contact |
DEBBIE IAMPIETRO |
Correspondent |
SUTURTEK INCORPORATED |
7 TIFFANY TRAIL |
HOPKINTON,
MA
01748
|
|
Correspondent Contact |
DEBBIE IAMPIETRO |
Regulation Number | 878.4830
|
Classification Product Code |
|
Date Received | 01/22/2003 |
Decision Date | 03/17/2003 |
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
|