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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mirror, General & Plastic Surgery
510(k) Number K870790
Device Name REFLECTIVE MIRROR/CO2 LASER SURG CAT. #902002-000
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 Number878.4800
Classification Product Code
FTX  
Date Received02/26/1987
Decision Date 04/01/1987
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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