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FDA 510(k) Application Details - K991159
Device Classification Name
Warmer, Blood, Non-Electromagnetic Radiation
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510(K) Number
K991159
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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More FDA Info for this Product Code
Date Received
04/07/1999
Decision Date
09/03/1999
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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