Device Classification Name |
suture, absorbable, synthetic, polyglycolic acid
|
510(k) Number |
K970317 |
Device Name |
MODIFIED E-PACK PROCEDURE KIT |
Applicant |
ETHICON, INC. |
ROUTE 22 WEST |
P.O. BOX 151 |
SOMERVILLE,
NJ
08876 -0151
|
|
Applicant Contact |
JOHN D PAULSON, PH.D. |
Correspondent |
ETHICON, INC. |
ROUTE 22 WEST |
P.O. BOX 151 |
SOMERVILLE,
NJ
08876 -0151
|
|
Correspondent Contact |
JOHN D PAULSON, PH.D. |
Regulation Number | 878.4493
|
Classification Product Code |
|
Date Received | 01/27/1997 |
Decision Date | 04/25/1997 |
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
|
|
|