DHS DISPOSABLE HOOD SYSTEM


Device Classification Name

gown, surgical

510(k) Number K021992
Device Name DHS DISPOSABLE HOOD SYSTEM
Original Applicant
BIOMET, INC.
p.o. box 587
warsaw, 
IN 
46581 -0587

Original Contact kacy arnold
Regulation Number 878.4040
Classification Product Code
FYA  
Date Received 06/18/2002
Decision Date 01/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No