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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K001129
Device Name PROLONG, MODELS PL50, PL100, PL150
Applicant
Life-Tech Intl., Inc.
4235 Greenbriar Dr.
Stafford,  TX  77477 -3995
Applicant Contact JEFF KASOFF
Correspondent
Life-Tech Intl., Inc.
4235 Greenbriar Dr.
Stafford,  TX  77477 -3995
Correspondent Contact JEFF KASOFF
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received04/07/2000
Decision Date 07/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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