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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K871068
Device Name DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER
Applicant
Lifestream Int'L, Inc.
10940 S. Wilcrest
Houston,  TX  77099
Applicant Contact ROGER MOGILL
Correspondent
Lifestream Int'L, Inc.
10940 S. Wilcrest
Houston,  TX  77099
Correspondent Contact ROGER MOGILL
Regulation Number878.4370
Classification Product Code
KKX  
Date Received03/18/1987
Decision Date 05/28/1987
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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