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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bur, Ear, Nose And Throat
510(k) Number K893499
Device Name CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASS
Applicant
Cmsi
P.O. Box 6174
South Bend,  IN  46660
Correspondent
Cmsi
P.O. Box 6174
South Bend,  IN  46660
Regulation Number874.4140
Classification Product Code
EQJ  
Date Received05/04/1989
Decision Date 11/16/1989
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
Predetermined Change
Control Plan Authorized		 No
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