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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 K061864
Device Name DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560
Applicant
Dukal Corp.
5 Plant Ave.
Hauppauge,  NY  11788
Applicant Contact PATRICK J LAMB
Correspondent
Dukal Corp.
5 Plant Ave.
Hauppauge,  NY  11788
Correspondent Contact PATRICK J LAMB
Regulation Number878.4040
Classification Product Code
FXX  
Date Received07/03/2006
Decision Date 09/15/2006
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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