FDA 510(k) Application Details - K874513

Device Classification Name Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

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510(K) Number K874513
Device Name Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Applicant MONAGHAN MEDICAL CORP.
FRANKLYN BLDG RT. 9 NORTH
P.O. BOX 978
PLATTSBURGH, NY US
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Contact JAMES A COCHIE
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Regulation Number 868.5640

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Classification Product Code CCQ
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Date Received 11/02/1987
Decision Date 12/30/1987
Decision SE - Substantially Equivalent
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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