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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Microscope, Ophthalmic
510(k) Number K843890
Device Name CUSTOM INSTRUMENT DRAPE
Applicant
Lifestream Int'L, Inc.
525 Julie Rivers Dr.
Suite 100
Sugar Land,  TX  77478
Applicant Contact RICK WILBORN
Correspondent
Lifestream Int'L, Inc.
525 Julie Rivers Dr.
Suite 100
Sugar Land,  TX  77478
Correspondent Contact RICK WILBORN
Regulation Number878.4370
Classification Product Code
HMW  
Date Received10/02/1984
Decision Date 10/26/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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