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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 K003994
Device Name KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Applicant Contact JAMES A LEE
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Correspondent Contact JAMES A LEE
Regulation Number874.4250
Classification Product Code
ERL  
Date Received12/26/2000
Decision Date 04/13/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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