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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 K940461
Device Name ALEXANTRIPTOR
Applicant
Servicetrends, Inc.
2130 Barrett Park Dr. NE,
Suite 103
Kennesaw,  GA  30144
Applicant Contact JOHN WARLICK
Correspondent
Servicetrends, Inc.
2130 Barrett Park Dr. NE,
Suite 103
Kennesaw,  GA  30144
Correspondent Contact JOHN WARLICK
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/02/1994
Decision Date 06/02/1994
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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