ANCHORAGE CLOSURE DEVICE


Device Classification Name

suture, nonabsorbable, synthetic, polyethylene

510(k) Number K073096
Device Name ANCHORAGE CLOSURE DEVICE
Applicant
EPITEK, INC.
4801 w. 81st street
suite 105
bloomington, 
MN 
55437

Applicant Contact werner hampl
Correspondent
EPITEK, INC.
4801 w. 81st street
suite 105
bloomington, 
MN 
55437

Correspodent Contact werner hampl
Regulation Number 878.5000
Classification Product Code
GAT  
Date Received 11/01/2007
Decision Date 02/07/2008
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