Device Classification Name |
Tissue Adhesive For The Topical Approximation Of Skin
|
510(k) Number |
K121976 |
Device Name |
AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE |
Applicant |
AESCULAP, INC. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Applicant Contact |
KATHY A RACOSKY |
Correspondent |
AESCULAP, INC. |
3773 Corporate Parkway |
Center Valley,
PA
18034
|
|
Correspondent Contact |
KATHY A RACOSKY |
Regulation Number | 878.4010
|
Classification Product Code |
|
Date Received | 07/05/2012 |
Decision Date | 05/17/2013 |
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
|