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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 K874296
Device Name INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER
Applicant
Ulti-Med Intl., Inc.
710 E. Remington Rd.
Schaumburg,  IL  60173
Applicant Contact JOHN FLOREN
Correspondent
Ulti-Med Intl., Inc.
710 E. Remington Rd.
Schaumburg,  IL  60173
Correspondent Contact JOHN FLOREN
Regulation Number878.4040
Classification Product Code
FXX  
Date Received10/20/1987
Decision Date 01/07/1988
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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