Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K981531 |
Device Name |
SUTURE PLACEMENT DEVICE AND ACCESSORIES |
Applicant |
LSI SOLUTIONS |
2144 BRIGHTON-HENRIETTA TOWN |
LINE RD. |
ROCHESTER,
NY
14623
|
|
Applicant Contact |
JUDE S SAUER |
Correspondent |
LSI SOLUTIONS |
2144 BRIGHTON-HENRIETTA TOWN |
LINE RD. |
ROCHESTER,
NY
14623
|
|
Correspondent Contact |
JUDE S SAUER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/29/1998 |
Decision Date | 07/13/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|