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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Thermal, Infusion Fluid
510(k) Number K914364
Device Name ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO.
Applicant
North American Technical Services Corp.
407 E. Main St.
P.O. Box 347
Port Jefferson,  NY  11777
Applicant Contact RICHARD LANZILLOTTO
Correspondent
North American Technical Services Corp.
407 E. Main St.
P.O. Box 347
Port Jefferson,  NY  11777
Correspondent Contact RICHARD LANZILLOTTO
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received10/01/1991
Decision Date 09/10/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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