LAC-MAC LIMITED INNERBLOC O.R. GOWN


Device Classification Name

gown, surgical

510(k) Number K030536
Device Name LAC-MAC LIMITED INNERBLOC O.R. GOWN
Applicant
LAC MAC, LTD.
10907 wareham court
austin, 
TX 
78739

Applicant Contact jeffrey o stull
Correspondent
LAC MAC, LTD.
10907 wareham court
austin, 
TX 
78739

Correspodent Contact jeffrey o stull
Regulation Number 878.4040
Classification Product Code
FYA  
Date Received 02/20/2003
Decision Date 05/06/2003
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