FDA 510(k) Application Details - K002409

Device Classification Name Warmer, Thermal, Infusion Fluid

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510(K) Number K002409
Device Name Warmer, Thermal, Infusion Fluid
Applicant AUTOMATIC MEDICAL TECHNOLOGIES, INC.
3422 WEST PICO BLVD.
LOS ANGELES, CA 90019 US
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Contact MICHAEL MITSUNAGA
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Regulation Number 000.0000

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Classification Product Code LGZ
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Date Received 08/07/2000
Decision Date 06/28/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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