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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 K092824
Device Name N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695
Applicant
Alpha Protech, Inc.
236 N. 2200 W.
Salt Lake City,  UT  84116
Applicant Contact DAVID KITCHEN
Correspondent
Alpha Protech, Inc.
236 N. 2200 W.
Salt Lake City,  UT  84116
Correspondent Contact DAVID KITCHEN
Regulation Number878.4040
Classification Product Code
MSH  
Date Received09/14/2009
Decision Date 10/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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