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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 K952962
Device Name EZ-PERSONAL PROTECTION KIT
Applicant
Safetec of America, Inc.
1055 E. Delavan Ave.
Buffalo,  NY  14215
Applicant Contact ROBERT O DEAN
Correspondent
Safetec of America, Inc.
1055 E. Delavan Ave.
Buffalo,  NY  14215
Correspondent Contact ROBERT O DEAN
Regulation Number878.4040
Classification Product Code
FXX  
Date Received06/26/1995
Decision Date 09/27/1995
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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