Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K043388 |
Device Name |
PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH |
Applicant |
PEGASUS BIOLOGICS, INC. |
10 PASTEUR ST. |
SUITE 150 |
IRVINE,
CA
92618
|
|
Applicant Contact |
MUIR S MEINHOLD |
Correspondent |
PEGASUS BIOLOGICS, INC. |
10 PASTEUR ST. |
SUITE 150 |
IRVINE,
CA
92618
|
|
Correspondent Contact |
MUIR S MEINHOLD |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/09/2004 |
Decision Date | 08/05/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|