FDA 510(k) Application Details - K961077

Device Classification Name Spirometer, Therapeutic (Incentive)

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510(K) Number K961077
Device Name Spirometer, Therapeutic (Incentive)
Applicant HEALTHSCAN PRODUCTS, INC.
908 POMPTON AVE.
UNIT B2
CEDAR GROVE, NJ 07009-1292 US
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Contact LAUREN R ZIEGLER
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Regulation Number 868.5690

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Classification Product Code BWF
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Date Received 03/18/1996
Decision Date 07/15/1996
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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