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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 K942474
Device Name PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000
Applicant
Protectaide, Inc.
605 White Hills Dr.
Rockwall,  TX  75087
Applicant Contact JAN DAVIS
Correspondent
Protectaide, Inc.
605 White Hills Dr.
Rockwall,  TX  75087
Correspondent Contact JAN DAVIS
Regulation Number878.4040
Classification Product Code
FXX  
Date Received05/25/1994
Decision Date 10/18/1994
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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