Device Classification Name |
suture, absorbable, natural
|
510(k) Number |
K993695 |
Device Name |
LIGA-LOOP SUTURE APPLICATOR |
Applicant |
HYSTERX, INC. |
18732 SAGINAW |
IRVINE,
CA
92612
|
|
Applicant Contact |
JUDY F GORDON |
Correspondent |
HYSTERX, INC. |
18732 SAGINAW |
IRVINE,
CA
92612
|
|
Correspondent Contact |
JUDY F GORDON |
Regulation Number | 878.4830
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/02/1999 |
Decision Date | 04/13/2000 |
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
|