Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polypropylene
|
510(k) Number |
K100593 |
Device Name |
SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME |
Applicant |
LSI SOLUTIONS, INC. |
7796 VICTOR-MENDON RD. |
VICTOR,
NY
14564
|
|
Applicant Contact |
PETER SPATH |
Correspondent |
LSI SOLUTIONS, INC. |
7796 VICTOR-MENDON RD. |
VICTOR,
NY
14564
|
|
Correspondent Contact |
PETER SPATH |
Regulation Number | 878.5010
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/02/2010 |
Decision Date | 10/13/2010 |
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
|
|
|