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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 K913036
Device Name PLUME MASTER
Applicant
Sorex Medical
5725 W. Harold Gatty Dr.
Salt Lake City,  UT  84116
Applicant Contact JOSEPH SORENSON
Correspondent
Sorex Medical
5725 W. Harold Gatty Dr.
Salt Lake City,  UT  84116
Correspondent Contact JOSEPH SORENSON
Regulation Number878.5070
Classification Product Code
FYD  
Date Received07/09/1991
Decision Date 09/06/1991
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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