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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 K012602
Device Name CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP FACE MASKS-BLUE, PINK, WHITE, GREEN. CROSSTEX
Applicant
Crosstex Intl.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
Crosstex Intl.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number878.4040
Classification Product Code
FXX  
Date Received08/13/2001
Decision Date 01/22/2002
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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