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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K911150
Device Name SOREX SAFE-AIR
Applicant
Sorex Medical
5725 W. Harold Gatty Dr.
Salt Lake City,  UT  84116
Applicant Contact JOSEPH T SORENSON
Correspondent
Sorex Medical
5725 W. Harold Gatty Dr.
Salt Lake City,  UT  84116
Correspondent Contact JOSEPH T SORENSON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/15/1991
Decision Date 06/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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