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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K935779
Device Name AGAFAR FACE SHIELD
Applicant
Infection Control Products, Inc.
696 Main St.
P.O. Box 739
Gardendale,  AL  35071
Applicant Contact JOHN PATRICK RUSSELL
Correspondent
Infection Control Products, Inc.
696 Main St.
P.O. Box 739
Gardendale,  AL  35071
Correspondent Contact JOHN PATRICK RUSSELL
Regulation Number878.4040
Classification Product Code
LYU  
Date Received12/03/1993
Decision Date 02/01/1994
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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