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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
510(k) Number K211490
Device Name Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
Applicant
Stryker Corporation
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact John Chesney
Correspondent
Stryker Corporation
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact John Chesney
Regulation Number874.4250
Classification Product Code
ERL  
Subsequent Product Codes
DZJ   HBE  
Date Received05/13/2021
Decision Date 06/09/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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