FDA 510(k) Application Details - K050883

Device Classification Name Gas-Machine, Anesthesia

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510(K) Number K050883
Device Name Gas-Machine, Anesthesia
Applicant SAFER SLEEP LLC
P.O. BOX 3515
REDMOND, WA 98073-3515 US
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Contact STEVEN CHERNOFF
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Regulation Number 868.5160

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Classification Product Code BSZ
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Date Received 04/07/2005
Decision Date 11/04/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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