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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
Recalls CDRH Recalls
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