FDA 510(k) Application Details - K030396

Device Classification Name Nebulizer (Direct Patient Interface)

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510(K) Number K030396
Device Name Nebulizer (Direct Patient Interface)
Applicant B & B MEDICAL TECHNOLOGIES, INC.
6731 32ND ST., SUITE A&B
NORTH HIGHLANDS, CA 95660 US
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Contact STEPHEN W BRIGGS
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Regulation Number 868.5630

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Classification Product Code CAF
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Date Received 02/06/2003
Decision Date 05/07/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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