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5905 Regulation Name Noncontinuous ventilator IPPB Regulatory Class 11 Dated September 9 2013 Received September 11 2013 Dear Mr. Research Zi ps Logistics Proprietary or Trade Name Seattle-PAP Common/Usual Name Bubble CPAP System Classification Name/Code BZD - Noncontinuous ventilator IPPB CFR 868. Or Part 21 CFR 801 Subpart D Over-the-counter use 21 CFR 807 Subpart C PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH Office of Device Evaluation ODE...

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