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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 K021811
Device Name UNIDRIVE II PLUS DISPOSABLE TUBING SET
Applicant
MTP MEDICAL TECHNICAL PROMOTION GMBH
600 CORPORATE POINTE
CULVER CITY,  CA  90230
Applicant Contact JAMES A LEE
Correspondent
MTP MEDICAL TECHNICAL PROMOTION GMBH
600 CORPORATE POINTE
CULVER CITY,  CA  90230
Correspondent Contact JAMES A LEE
Regulation Number874.4250
Classification Product Code
ERL  
Date Received06/03/2002
Decision Date 06/19/2002
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
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