FDA 510(k) Application Details - K950380

Device Classification Name Stylet, Tracheal Tube

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510(K) Number K950380
Device Name Stylet, Tracheal Tube
Applicant POLAMEDCO, INC.
8295 A. LACIENEGA BLVD.
INGLEWOOD, CA US
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Contact JERRY HARRER
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Regulation Number 868.5790

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Classification Product Code BSR
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Date Received 01/31/1995
Decision Date 02/10/1995
Decision SE - Substantially Equivalent
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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