FDA 510(k) Application Details - K960854

Device Classification Name Nebulizer (Direct Patient Interface)

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510(K) Number K960854
Device Name Nebulizer (Direct Patient Interface)
Applicant PACESETTER, INC.
49 PLAIN ST.
NORTH ATTLEBORO, MA 02760-3577 US
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Contact STEVEN CLARKE
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Regulation Number 868.5630

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Classification Product Code CAF
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Date Received 03/01/1996
Decision Date 12/23/1996
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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