Device Classification Name |
polymer, ent synthetic-polyamide (mesh or foil material)
|
510(k) Number |
K132198 |
Device Name |
ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI |
Applicant |
CEREMED, INC. |
3643 LENAWEE AVE. |
LOS ANGELES,
CA
90016
|
|
Applicant Contact |
CHELSEA MITCHELL |
Correspondent |
CEREMED, INC. |
3643 LENAWEE AVE. |
LOS ANGELES,
CA
90016
|
|
Correspondent Contact |
CHELSEA MITCHELL |
Regulation Number | 874.3620
|
Classification Product Code |
|
Date Received | 07/16/2013 |
Decision Date | 09/12/2013 |
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
|
|
|