TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE


Device Classification Name

dressing, wound, drug

510(k) Number K080648
Device Name TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE
Applicant
ORE-MEDIX, LLC
7651 s. 700 west, suite 105
midvale, 
UT 
84047

Applicant Contact donald f grabarz
Correspondent
ORE-MEDIX, LLC
7651 s. 700 west, suite 105
midvale, 
UT 
84047

Correspodent Contact donald f grabarz
Classification Product Code
FRO  
Date Received 03/07/2008
Decision Date 05/07/2008
Decision

substantially equivalent

(SESE)

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Expedited Review Yes

Combination Product

Yes