Device Classification Name |
Suture, Absorbable, Synthetic, Polyglycolic Acid
|
510(k) Number |
K053636 |
Device Name |
MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE) |
Applicant |
MANI, INC. |
1301K STREET, N.W. |
SUITE 1100 - EAST TOWER |
WASHINGTON,
DC
20005 -3373
|
|
Applicant Contact |
DAVID J BLOCH |
Correspondent |
MANI, INC. |
1301K STREET, N.W. |
SUITE 1100 - EAST TOWER |
WASHINGTON,
DC
20005 -3373
|
|
Correspondent Contact |
DAVID J BLOCH |
Regulation Number | 878.4493
|
Classification Product Code |
|
Date Received | 12/29/2005 |
Decision Date | 03/14/2006 |
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
|
Recalls |
CDRH Recalls
|
|
|