UNITE BIOMATRIX

Device Classification Name

dressing, wound, collagen

510(k) Number K071425
Device Name UNITE BIOMATRIX
Applicant
PEGASUS BIOLOGICS, INC.
6 jenner
suite 150
irvine, 
CA 
92618

Applicant Contact pamela misajon
Correspondent
PEGASUS BIOLOGICS, INC.
6 jenner
suite 150
irvine, 
CA 
92618

Correspodent Contact pamela misajon
Classification Product Code
KGN  
Date Received 05/23/2007
Decision Date 06/20/2007
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

Yes