AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE


Device Classification Name

tissue adhesive for the topical approximation of skin

510(k) Number K111959
Device Name AESCULAP HISTOACRYL AND HISTOACRYL BLUE 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

Correspodent Contact kathy a racosky
Regulation Number 878.4010
Classification Product Code
MPN  
Date Received 07/11/2011
Decision Date 02/06/2012
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