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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal, X-Ray Detectable
510(k) Number K863089
Device Name DISPOSABLE LASER SPONGE SURGIMEDICS, 902001-000
Applicant
Lifestream Int'L, Inc.
525 Julie Rivers Dr.
Suite 100
Sugar Land,  TX  77478
Applicant Contact MIKE BARBOUR
Correspondent
Lifestream Int'L, Inc.
525 Julie Rivers Dr.
Suite 100
Sugar Land,  TX  77478
Correspondent Contact MIKE BARBOUR
Regulation Number878.4450
Classification Product Code
GDY  
Date Received08/13/1986
Decision Date 10/14/1986
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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