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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 K946001
Device Name EMERGENCY RESPONSE SAFETY KIT
Applicant
Ani Safety, Inc.
5725 W. Howard St.
P.O. Box 228
Skokie,  IL  60076
Applicant Contact KRIKOR TOPOUZIAN
Correspondent
Ani Safety, Inc.
5725 W. Howard St.
P.O. Box 228
Skokie,  IL  60076
Correspondent Contact KRIKOR TOPOUZIAN
Regulation Number878.4040
Classification Product Code
FXX  
Date Received11/21/1994
Decision Date 06/09/1995
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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