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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K082258
Device Name CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR
Applicant
Crosstex International
14605 28th Ave. N.
Minneapolis,  MN  55447
Applicant Contact RICHARD M ORMSBEE
Correspondent
Crosstex International
14605 28th Ave. N.
Minneapolis,  MN  55447
Correspondent Contact RICHARD M ORMSBEE
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/08/2008
Decision Date 10/16/2008
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
Predetermined Change
Control Plan Authorized		 No
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