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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 K862815
Device Name LASER SURGICAL ROD
Applicant
Lifestream Int'L, Inc.
10940 S. Wilcrest
Houston,  TX  77099
Applicant Contact MIKE BARBOUR
Correspondent
Lifestream Int'L, Inc.
10940 S. Wilcrest
Houston,  TX  77099
Correspondent Contact MIKE BARBOUR
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/24/1986
Decision Date 11/17/1986
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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