Device Classification Name |
polymer, ent synthetic, porous polyethylene
|
510(k) Number |
K083621 |
Device Name |
MEDPOR CUSTOMIZED SURGICAL IMPLANT |
Applicant |
POREX SURGICAL, INC. |
15 DART RD. |
NEWNAN,
GA
30265
|
|
Applicant Contact |
JERRI L MANN |
Correspondent |
POREX SURGICAL, INC. |
15 DART RD. |
NEWNAN,
GA
30265
|
|
Correspondent Contact |
JERRI L MANN |
Regulation Number | 874.3620
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/08/2008 |
Decision Date | 02/03/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|