Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polypropylene
|
510(k) Number |
K070243 |
Device Name |
SUTRALENE POLYPROPYLENE SUTURES |
Applicant |
VISIONARY MEDICAL SUPPLIES, INC. |
800 LEVANGER LN. |
STOUGHTON,
WI
53589
|
|
Applicant Contact |
Gary Syring |
Correspondent |
VISIONARY MEDICAL SUPPLIES, INC. |
800 LEVANGER LN. |
STOUGHTON,
WI
53589
|
|
Correspondent Contact |
Gary Syring |
Regulation Number | 878.5010
|
Classification Product Code |
|
Date Received | 01/25/2007 |
Decision Date | 04/17/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|