FDA 510(k) Application Details - K991160

Device Classification Name Warmer, Blood, Non-Electromagnetic Radiation

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510(K) Number K991160
Device Name Warmer, Blood, Non-Electromagnetic Radiation
Applicant STIHLER ELECTRONIC GMBH
30 NORTHPORT RD.
SOUND BEACH, NY 11789-1734 US
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Contact RICHARD C LANZILLOTTO
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Regulation Number 864.9205

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Classification Product Code BSB
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Date Received 04/07/1999
Decision Date 09/02/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee HE - Hematology
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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