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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Ear, Nose, And Throat Stereotaxic Instrument
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
Applicant Contact BECKY DITTY
Correspondent
STRYKER CORPORATE
4100 E. MILHAM AVE.
KALAMAZOO,  MI  49001
Correspondent Contact BECKY DITTY
Regulation Number882.4560
Classification Product Code
PGW  
Date Received06/11/2014
Decision Date 09/08/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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