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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respirator, Surgical
510(k) Number K070692
Device Name DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK
Applicant
Dukal Corporation
5 Plant Ave.
Hauppauge,  NY  11788
Applicant Contact PATRICK J LAMB
Correspondent
Dukal Corporation
5 Plant Ave.
Hauppauge,  NY  11788
Correspondent Contact PATRICK J LAMB
Regulation Number878.4040
Classification Product Code
MSH  
Date Received03/13/2007
Decision Date 05/30/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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