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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 K040333
Device Name VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS
Applicant
Valumax Intl., Inc.
848 Hausman Rd.
Allentown,  PA  18104
Applicant Contact JANET JIA
Correspondent
Valumax Intl., Inc.
848 Hausman Rd.
Allentown,  PA  18104
Correspondent Contact JANET JIA
Regulation Number878.4040
Classification Product Code
FXX  
Date Received02/11/2004
Decision Date 06/07/2004
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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