DEROYAL GOWNS, STERILE, NON-STERILE


Device Classification Name

gown, surgical

510(k) Number K030364
Device Name DEROYAL GOWNS, STERILE, NON-STERILE
Applicant
DEROYAL INDUSTRIES, INC.
200 debusk ln.
powell, 
TN 
37849

Applicant Contact audrey daniels
Correspondent
DEROYAL INDUSTRIES, INC.
200 debusk ln.
powell, 
TN 
37849

Correspodent Contact audrey daniels
Regulation Number 878.4040
Classification Product Code
FYA  
Date Received 02/04/2003
Decision Date 04/28/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No