CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS


Device Classification Name

mask, surgical

510(k) Number K111343
Device Name CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS
Applicant
CROSSTEX INTERNATIONAL, INC.
14605 28th avenue north
minneapolis, 
MN 
55447

Applicant Contact richard m ormsbee
Correspondent
CROSSTEX INTERNATIONAL, INC.
14605 28th avenue north
minneapolis, 
MN 
55447

Correspodent Contact richard m ormsbee
Regulation Number 878.4040
Classification Product Code
FXX  
Date Received 05/13/2011
Decision Date 10/06/2011
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