SKINTEMP II


Device Classification Name

dressing, wound, collagen

510(k) Number K122325
Device Name SKINTEMP II
Applicant
HUMAN BIOSCIENCES, INC.
2913, 209th lane nw
oak grove, 
MN 
55011

Applicant Contact jack slovick
Correspondent
HUMAN BIOSCIENCES, INC.
2913, 209th lane nw
oak grove, 
MN 
55011

Correspodent Contact jack slovick
Classification Product Code
KGN  
Date Received 08/01/2012
Decision Date 10/26/2012
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No