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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 K926438
Device Name ACTION MEDTEK FACE SHIELD
Applicant
Action Eyewear Corp.
1401 Duff Dr., Unit 100
Fort Collin,  CO  80524
Correspondent
Action Eyewear Corp.
1401 Duff Dr., Unit 100
Fort Collin,  CO  80524
Regulation Number878.4040
Classification Product Code
LYU  
Date Received12/23/1992
Decision Date 08/18/1993
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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