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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 K012906
Device Name ANIMEC, MODELS AM-2S-4 AND AM-2S-5
Applicant
Elltec Co., Ltd.
Shirakawa # 6 Bldg.
2-18-5, Nishiki, Naka-Ku
Nagoya,  JP 460-0003
Applicant Contact GENSHIRO OGAWA
Correspondent
Elltec Co., Ltd.
Shirakawa # 6 Bldg.
2-18-5, Nishiki, Naka-Ku
Nagoya,  JP 460-0003
Correspondent Contact GENSHIRO OGAWA
Regulation Number880.5725
Classification Product Code
LGZ  
Subsequent Product Code
BSB  
Date Received08/29/2001
Decision Date 10/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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