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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 K946003
Device Name INTEC FULL FACE SHIELD
Applicant
Intec Industries, Inc.
3804 First Ave. N.
Birmingham,  AL  35222
Applicant Contact FRANK LEE
Correspondent
Intec Industries, Inc.
3804 First Ave. N.
Birmingham,  AL  35222
Correspondent Contact FRANK LEE
Regulation Number878.4040
Classification Product Code
LYU  
Date Received12/09/1994
Decision Date 06/28/1995
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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