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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 K946343
Device Name INTEC EXTENDED EYE SHIELD WITH MASK
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
FXX  
Date Received12/30/1994
Decision Date 03/22/1995
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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