FDA 510(k) Application Details - K141551

Device Classification Name

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510(K) Number K141551
Device Name PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES)
Applicant STRYKER CORPORATE
4100 E. MILHAM AVE.
KALAMAZOO, MI 49001 US
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Contact BECKY DITTY
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Regulation Number

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Classification Product Code PGW
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Date Received 06/11/2014
Decision Date 09/08/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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