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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Exhaust, Surgical
510(k) Number K952981
Device Name FILTRESSE, SMOKE FILTRATION SYSTEM, 115 VAC & 230 VAC
Applicant
Utah Medical Products, Inc.
7043 S. 300 W.
Midvale,  UT  84047
Applicant Contact JOHN W SMITH
Correspondent
Utah Medical Products, Inc.
7043 S. 300 W.
Midvale,  UT  84047
Correspondent Contact JOHN W SMITH
Regulation Number878.5070
Classification Product Code
FYD  
Date Received06/28/1995
Decision Date 08/28/1995
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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