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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Autotransfusion
510(k) Number K082923
Device Name PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C
Applicant
Life-Tech, Inc.
4235 Greenbriar Dr.
Stafford,  TX  77477
Applicant Contact JEFF KASOFF
Correspondent
Life-Tech, Inc.
4235 Greenbriar Dr.
Stafford,  TX  77477
Correspondent Contact JEFF KASOFF
Regulation Number868.5830
Classification Product Code
CAC  
Date Received10/01/2008
Decision Date 10/24/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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