FDA 510(k) Application Details - K963633

Device Classification Name Accessory To Continuous Ventilator (Respirator)

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510(K) Number K963633
Device Name Accessory To Continuous Ventilator (Respirator)
Applicant PURITAN BENNETT CORP.
15222 DEL AMO AVE.
TUSTIN, CA 92780 US
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Contact RAY PIZINGER
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Regulation Number 868.5895

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Classification Product Code MOD
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Date Received 09/11/1996
Decision Date 12/16/1996
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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