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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tracheotome
510(k) Number K933570
Device Name RESOLUTION(TM) HIP STEM
Applicant
Wrightmedicaltechnologyinc
5677 Airline Rd.
Arlington,  TN  38002
Applicant Contact JUDY ENGLISH
Correspondent
Wrightmedicaltechnologyinc
5677 Airline Rd.
Arlington,  TN  38002
Correspondent Contact JUDY ENGLISH
Regulation Number874.4420
Classification Product Code
LJW  
Date Received07/23/1993
Decision Date 03/07/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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