DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE

Device Classification Name

gown, surgical

510(k) Number K033057
Device Name DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE
Applicant
DEROYAL
200 debusk ln.
powell, 
TN 
37849

Applicant Contact sharon cook
Correspondent
DEROYAL
200 debusk ln.
powell, 
TN 
37849

Correspodent Contact sharon cook
Regulation Number 878.4040
Classification Product Code
FYA  
Date Received 09/29/2003
Decision Date 11/20/2003
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