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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 K992061
Device Name PULSTAR
Applicant
Lasermed, Inc.
8050 S. 1300 W.
West Jordan,  UT  84088
Applicant Contact CALVIN D OSTLER
Correspondent
Lasermed, Inc.
8050 S. 1300 W.
West Jordan,  UT  84088
Correspondent Contact CALVIN D OSTLER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/18/1999
Decision Date 07/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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