Device Classification Name |
suture, absorbable, synthetic, polyglycolic acid
|
510(k) Number |
K041806 |
Device Name |
PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP |
Applicant |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
249 VANDERBILT AVE. |
NORWOOD,
MA
02062
|
|
Applicant Contact |
RUTH C FORSTADT |
Correspondent |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
249 VANDERBILT AVE. |
NORWOOD,
MA
02062
|
|
Correspondent Contact |
RUTH C FORSTADT |
Regulation Number | 878.4493
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/06/2004 |
Decision Date | 08/03/2004 |
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
|
|
|