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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 K200318
Device Name UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece
Applicant
KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Ave.
Los Angeles,  CA  90245
Applicant Contact Alita McElroy
Correspondent
KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Ave.
Los Angeles,  CA  90245
Correspondent Contact Alita McElroy
Regulation Number874.4250
Classification Product Code
ERL  
Date Received02/07/2020
Decision Date 10/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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