Device Classification Name |
suture, absorbable, synthetic, polyglycolic acid
|
510(k) Number |
K063462 |
Device Name |
NEATSTITCH NEATCLOSE SUTURING DEVICE |
Applicant |
NEAT STITCH LTD. |
HAHADAS 1 ST |
OR AKIVA,
IL
30600
|
|
Applicant Contact |
YOSSI MUNCHER, PH.D. |
Correspondent |
NEAT STITCH LTD. |
HAHADAS 1 ST |
OR AKIVA,
IL
30600
|
|
Correspondent Contact |
YOSSI MUNCHER, PH.D. |
Regulation Number | 878.4493
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/15/2006 |
Decision Date | 01/12/2007 |
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
|
|
|