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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 K102092
Device Name PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES
Applicant
Prestige Ameritech
7201 Iron Horse Blvd.
North Richland Hills,  TX  76180
Applicant Contact BARARA MCCARTY
Correspondent
Prestige Ameritech
7201 Iron Horse Blvd.
North Richland Hills,  TX  76180
Correspondent Contact BARARA MCCARTY
Regulation Number878.4040
Classification Product Code
MSH  
Date Received07/27/2010
Decision Date 10/06/2010
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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